Author: Barbara W. Unger

FDA 483 Violations

Posted FDA 483 Violations | Week of 9/16/18

It’s 483 study time, and our GMP expert has extracted the key points in this week’s featured 483 posted by the FDA. Violations ranged from failing to provide scientific reasons for invalidating OOS results to failing to prevent colored residues on equipment.

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Warning Letters

Week of September 9th 2018 | FDA Sent These Warning Letters to Pharma/Device Companies

FDA posted 7 warning letters this week including 2 warning letters to Medtronic regarding non-conformance that resulted in a Class I recall of a defibrillator earlier in 2018. In addition, warning letters were issued to 1 firm in Canada and 1 firm in China. And, in the largest coordinated enforcement effort in the FDA’s history, 1,300 warning letters were issued to a single industry.

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FDA/GMP Updates | August 2018

FDA/GMP Updates | August 2018

An efficient summary of all things FDA/GMP related for the entire month of August 2018. Warning letters, a refusal of an FDA inspection, new guidance, etc. See the complete run down here.

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MHRA Data Integrity

Part 1 | 2015 vs 2018 – MHRA Data Integrity Guidance

MHRA published a revision to their 2015 Data Integrity Guidance. The 2018 revision, in general, provides more detail and granularity than the 2015 version. Several items from the 2015 version are absent from the 2018 version. However, some items are more detailed in the 2018 version. We address all within this post and identify the nature of the addition, deletion, or revision.

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