GMP Tips - FDA Enforcement Report - August 16, 2006

Some interesting observations were contained in FDA's Enforcement Report last week.
Recent recalls cited the following reasons:

1. Packaging mix-up: The outer packaging is labeled as Hydralazine Hydrochloride, 100 mg tablets, but the unit dose blister strips inside the outer packaging may contain and be labeled as Benztropine Mesylate, 0.5 mg tablets.

2. Lorazepam 1 mg tablets packaged and distributed as Lorazepam 2 mg tablets.

3. Labeling: Incorrect package insert (older version) was sent instead of revised current version.

Read these GMP violations and others at:
http://www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources and scroll down to FDA Enforcement Report Aug 9, 2006

Training Tip
Use examples like these in your GMP Training sessions to reinforce the need to follow procedures.

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