FDA WARNING_LETTER - Jerome Stevens Pharmaceuticals, Inc - September 12, 2007

On August 27, 2007, through September 12, 2007, an FDA inspection of Jerome Stevens Pharmaceuticals, Inc.'s drug manufacturing facility in Bohemia, New York, revealed significant deviations from Current Good Manufacturing Practice (CGMP) Regulations (21 CFR Parts 210 and 211) and Adverse Drug Experience Reporting Regulations (21 CFR Parts 314.80 and 314.81). These violations render their drug products, including Aspirin, Butalbital, Caffeine, Codeine Phosphate Capsules, Digoxin Tablets, and Unithroid (Levothyroxine Sodium) Tablets, adulterated under Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate Annual Reviews (21 CFR § 211.180(e)(1)):** Failure to address trends in complaints, investigations, rejected/reprocessed batches, and other manufacturing issues. This is a repeat violation from a 2005 inspection. 2. **Failure to Investigate Discrepancies (21 CFR § 211.192):** Inadequate investigation and documentation of out-of-specification results, such as a Butalbital assay deviation, without proper assessment or corrective/preventative actions. This is a repeat violation from 2002