L. Perrigo Company – FDA 483, Nov 7, 2008
The FDA Form 483 details multiple significant violations at a drug manufacturing facility, encompassing issues with quality control, record-keeping, and product release.
**Key Violations and Observations:**
* **Unapproved Expiration Dates:** Numerous drug lots, including Sleep Aid Tablets (Doxylamine Succinate 25 mg), Naproxen Sodium 220 tablets/caplets, and APAP 500 mg Gelcaps, were released with unapproved expiration dates (36 or 48 months) not compliant with established procedures. * **Inadequate Investigation of Out-of-Specification (OOS) Results:** * Multiple lots of Natural Senna Laxative Tablets, some manufactured by (b)(4), failed stability assays and remained on the market despite unresolved investigations. Examples include lots 7B0991, 7G0903, and 6GE0670. * An OOS release assay for Natural Senna Laxative Tablet lot 7E1788 remained unresolved, and subsequent lots were released without prior testing. * OOS stability results for Chlorpheniramine Maleate Tablet lot 6F1461 (JB Laboratories) and 81 mg Enteric Coated Aspirin tablet lot 6E0507 (b)(4) were not resolved. * **Failure to Review Discrepancies:**
ID · e35921dd-708b-4d92-a3b1-57a2ea97e42a
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