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The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.

The U.S. Food and Drug Administration posted a photo:

The U.S. Food and Drug Administration (FDA) is a science-based regulatory agency working to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

This photo is free of all copyright restrictions and available for use and redistribution without permission. Credit to the U.S. Food and Drug Administration is appreciated but not required.

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From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304-  ANSI AAMI IEC   62304:2006/A1:2016 62366-1:2015-  Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More]

From : Communities>>Regulatory Open Forum
Hello Anonymous  You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion. Biocompatibility if used, is generating test [More]

From : Communities>>Regulatory Open Forum
Hello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More]

Anx·i·ety (noun)
The state of uneasiness caused by apprehension of possible misfortune.

Yep.  That’s the word that comes to mind whenever anyone mentions FDA inspections.

But anxiety often stems from a lack of control, and in a regulatory inspection, you have more control than you might think.  There are many steps you can take -- before, during, and even after an inspection is over -- that can give you a fair degree of control over the outcome.   Here, Polaris auditors Lauren Kelley and Michele Commins share some of those steps with you.



Pre-inspection Preparation
For-cause inspections may be unannounced, but routine FDA inspections of submission data are scheduled in advance*.  That means most inspections are not pop quizzes; they’re final exams.
Remember how happy you were when a teacher gave you access to a prior year’s exam to study from?  You knew the type of questions that would be asked.  You knew how to prepare.

So this is the first tip we’d like to share.  FDA has, indeed, given you a copy of their exam in advance, in the form of its Compliance Program Guidance Manual, CPGM 7348.811.  This is the document all FDA field investigators use to conduct inspections at clinical sites.  It outlines in great detail what documents investigators will review, what dates they’re going to verify, what processes they’ll evaluate, what data they’ll collect, and what records they’re going to compare.  Despite its rather uninspired title, this is your copy of the final exam.

You know cramming is a risky strategy, so the earlier you get familiar with the CPGM the better.  Inspection readiness is a state of preparedness more than it is a laundry list of activities; it takes some time to get there.

When the Inspector’s in the House
According to the CPGM, one of the first pieces of information the FDA investigator will obtain is a list of all of the studies performed by the clinical investigator, including protocol number, sponsor, and study dates.  So even though FDA has scheduled its inspection with you, and has told you what study the investigator is coming to inspect, any study is fair game.  An FDA investigator can look at any document she wants, or talk to any staff member he chooses, whether related to the “assigned” study or not.

Most of your preparation will have been study-specific; questions about other studies will catch your staff off-guard, and a review of records for other studies may find them less than inspection-ready.  So here’s our second tip.   Avoid anything that might pique the investigator’s curiosity about a study that is not the original subject of the inspection.  Make sure the room you reserve as your investigator’s “home base” is free of any documents, reports, notes, phone lists, and post-its.  Make sure you tidy up offices, workspaces, and facilities site-wide, and keep extraneous chatter in check.

After the Visit
If your FDA inspection resulted in zero observations, then stop reading, thank your awesome staff members, and go celebrate.  If, however, you did receive a Form FDA 483, it’s probably not the end of the world, but you do have some work to do.  Our third tip is this:  remember that the sponsor/CRO is your ally here.  They have as much invested in FDA’s assessment of your study data as you do, and they have the regulatory, QA, even legal resources that you might not.   You’re not required to formally respond to 483s, but if you do, you’re likely to receive a more favorable Establishment Inspection Report (EIR) in the end.  Let your sponsor/CRO help you with your response.

Tips Do Not a Plan Make
Tips are helpful, but you’ll need more than that to ensure a successful FDA site inspection.  You need an inspection readiness plan -- a plan that you document and keep current.  All site staff members need to train on the inspection procedures and the individual roles they will play.  (Fourth tip: don’t forget to train your temporary employees; an office temp working at the receptionist desk could be the first person your FDA investigator speaks with.)

A Last Thought
Inspections are stress-inducing events, and nervous people make mistakes.  Investigators know this, and expertly exercise the “pregnant pause,” knowing how difficult it is for people to withstand an excruciating silence without volunteering unsolicited information.

So one last tip:  conduct a mock inspection before the FDA comes to visit.  It will stress test your procedures and identify improvements you need to implement.  A thorough mock inspection will give staff members an opportunity to rehearse their roles and interview techniques so they can execute your plan and speak to the FDA investigator with confidence.

_______________________________
* For-cause inspections are also known as Investigator-oriented, and routine inspections are also known as study-oriented.

 A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites

    WARNING LETTER

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

December 1, 2018

Mr. Kris Kringle, Owner
Santa’s Workshop, LLC
1225 Santa Clause Way
North Pole, Arctic Circle
 
Dear Mr. Kringle:

The U.S. FDA inspected your manufacturing facility, Santa’s Workshop, LLC at
1225 Santa Claus Way, North Pole Arctic Circle, from April 2 to April 20, 2018.

This warning letter summarizes significant violations of CGMP regulations for finished product. See 21 CFR, parts 210 and 211. During our inspection, our investigators observed specific violations including, but not limited to, the following.

CGMP Violations

1.    Your firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of product has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions (21 CFR 211.25(a) and 211.28).

Many members of your Enterprise Labor Force (ELF) unit lacked sufficient prior experience for designing and assembling (b)(4). At the time of our inspection, no ELF members had received training on CGMPs, and most were unaware of their responsibilities in the areas of cleanliness and proper attire. Hands and faces were often coated with chocolate, and bells on hats and shoes prevented protective apparel from attaining a proper fit. More generally, factory staff demonstrated an undisciplined, almost gleeful disregard for quality procedures. On three separate occasions, at critical stages of the manufacturing process, floor workers erupted into spontaneous song and dance.



Your written response of May 18, 2018 is inadequate because it does not address these training and experience deficiencies. While endearing, the ability to “sit on a shelf” or “live in a hollow tree” does not constitute acceptable manufacturing experience. Candy coating does not qualify as protective covering. And sticking one’s hands in a nearby snowdrift is not a recognized sanitation procedure. “Pure as the driven snow” is not a thing. Especially with all those reindeer knocking about.

2.    Your firm failed to maintain a system by which the distribution of each lot of product can be readily determined to facilitate its recall if necessary (21 CFR 211.150(b)).

Product distribution records were incomplete and, in the event of a recall, would be insufficient to identify all product recipients.

Your written response of May 18, 2018 is inadequate. Santa’s Own Procedures (SOPs) are insufficient to capture the information required to conduct a thorough recall.  Mr. Kringle may well know which customers are naughty and which are nice -- who’s good, who’s bad, who’s sleeping, and who’s awake, but this information is not written down and, in the opinion of our investigators, would be of limited value if it were.

3.    Your firm failed to store product at an appropriate temperature to ensure the identity, strength, quality, and purity of the products are not affected (21 CFR 211.142(b)).

Entire sections of the facility lacked effective air conditioning, resulting in destruction of all (b)(4) warehoused in two large storage rooms. A third inadequately cooled room was not in use, and except for some miscellaneous items – a couple hunks of coal, a corncob pipe, and a large, oddly sad puddle of water – the room was all but empty.

Your written response of May 18, 2108 was inadequate. FDA isn’t really sure what to do with “that old silk hat we found” in your response package.

4.    Products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed (21 CFR 211.165(f)).

While not strictly a violation of 21 CFR 211.165(f), the rejection and quarantining procedures your firm follows for products that fail to meet established criteria is concerning. While it’s appropriate to reject a (b)(4) that swims, a (b)(4) with square wheels, a (b)(4) that shoots jelly, and a (b)(4) that rides an ostrich, exile to a remote island ruled by a flying lion is, in a word, extreme. Your firm also rejected and exiled a (b)(4)-in-a-box for what was almost certainly an easily remediated labeling problem; reprocessing would have been a more appropriate course of action. Also, we just have to know. Seriously. WHAT WAS WRONG WITH THE DOLLY???

5.    Your firm failed to establish adequate acceptance criteria for sampling and testing necessary to assure that batches of product meet appropriate specifications as a condition of their approval and release (21 CFR 211.165(d)).

Sampling procedures consisted of pulling each finished batch of (b)(4) out of a hot oven, taking a few nibbles, and declaring it “Jingle-icious.” Testers would frequently adulterate samples by submersing and saturating them with milk. These procedures are totally without scientific rigor. Furthermore, sampling was not restricted to members of the Quality Control Unit, but was extended to the entire plant floor. At times, sampling frequency was so high that there was very little, if any, of (b)(4) left to distribute. (On a personal note, our investigators would like to express their appreciation for the opportunity to participate in the testing activity. All the batches they sampled exceeded the strictest statistical quality control criteria, excepting the fruitcake, which could have benefited from additional stability testing and an earlier expiry date.)

Conclusion

Violations in this letter are not intended as an all-inclusive list. Typically the manufacturer is responsible for investigating violations, determining their root causes, and preventing their recurrence. However, in this case we’re going to make an exception. Though your methods and procedures are unconventional and frequently out of compliance with regulations, they are not wholly without merit. Our investigators have never experienced such a high level of workplace morale -- some calling it “downright merry” – and believe it warrants further observation. Investigators have suggested a series of mutually consultative visits to your workshop. Music, dance, batch samples, reindeer games, and the occasional adulterated eggnog are highly encouraged.

Sincerely,
/S/
Holly Bush
Division Director/OPQO Division I
North Pole District Office

Editor's note: This story was originally published Friday morning, and has been updated to reflect the FDA's decision regarding the drug later that day. A U.S. approval decision for a major drug planned to be marketed by Cambridge-based Sanofi Genzyme that had been expected last Friday has been delayed due to “deficiencies” found during a manufacturing site inspection in France. In its third quarter report, released Friday morning, French drugmaker Sanofi (NYSE: SNY) disclosed that “manufacturing…

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