What is a Facility – Updated

September 2016, I blogged about the draft FDA Guidance Facility Definition Under Section 503B of the FD&C act.  In May 2018, the draft guiance was approved and published in the Federal Register and is available here. Industry Questions: FDA has been asked whether an outsourcing facility can create a separate area within its facility for compounding according to […]

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ISPE Vision to Reality: Delivering Next Generation Therapies

This year’s theme for the ISPE 2018 Annual Meeting and EXPO is Vision to Reality: Delivering Next Generation Therapies. One of the frequent challenges when delivering next generation therapies is available manufacturing space.  Either the existing facility is committed to current products with no excess capacity, or the time/cost to reconfigure the existing facility to meet […]

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Validation

In a recently posted FDA Warning Letter, USFDA provided a clear expectation concerning the purpose of validation: The purpose of validation is to determine whether your processes can operate within established parameters to assure consistent batch uniformity, integrity, and drug quality. Reliable and well-documented batch operations are essential to ensuring process control and drug quality. The firm […]

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Trends in FDA Inspection Observations

What are the top 5 citations from FDA inspections for the past 3-years (2018-2020)? #1 For each of the past 3-years 21 CFR 211.22(D) has been the most frequent observations in FDA inspections.  The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.  According to […]

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Thoughts on Responses to FDA Inspections

Over the past few years, I have read hundreds of FDA warning letters.  A common observation that I wanted to share was the apparent difference in perceptions between the inspected organization and the FDA.  My opinion is that in most cases, the inspected organization takes the FDA findings for this instance in time and often […]

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Supplier Qualification

In a recently posted warning letter, a drug manufacturer was cited for receipt and delivery of adulterated drugs.  As cited in the warning letter: We note that an inspection of records at your facility and a review of FDA import data demonstrated that FDA has, in the past, taken regulatory action against at least 23 of your […]

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Supplier CofA’s – Do I need to do anything?

A common observation during FDA inspections is a failure of the drug company to perform incoming testing of raw materials and relying solely upon the suppliers CofA.  A common misconception is that I can simply accept the CofA from my supplier with no testing or qualification of the supplier. This is not acceptable per the […]

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Current Inspection Trends From FDA Warning Letters

A review of warning letters posted on September 10, 2013, to the FDA website was conducted.  Four of thirteen warning letters were issued by CDRH with a subject of Quality System Regulation for Medical Devices/Adulterated.  Twenty-seven violations were identified at these four manufacturers.  A break-down of the identified violations follows: Citation         […]

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Repeated Failures

What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective? In a recent warning letter, FDA identified four citations: While not numbered as an observation, the FDA also commented that the firm does not always follow their current SOPs. Finally – FDA made […]

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