FDA WARNING_LETTER - Elge, Inc. - February 14, 2008

An FDA inspection of Elge, Inc.'s facility in Rosenberg, Texas, from January 14 to February 14, 2008, revealed significant violations. The company manufactures prescription and OTC drug products, which were found to be adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (Act) due to non-conformity with Current Good Manufacturing Practices (CGMP) regulations (21 CFR Part 211).

Key violations include: 1. **Inadequate Laboratory Controls (21 CFR 211.160(b)(1))**: Failure to establish proper identity testing for incoming API raw materials (e.g., Dextromethorphan Tannate, Pseudoephedrine Tannate, d-Chlorpheniramine Tannate), with the USP <197K> FT-IR "Identity" test lacking the capability to detect physicochemical changes or distinguish between APIs. 2. **Insufficient Specifications (21 CFR 211.160(b))**: Absence of specifications for free Tannic Acid in tannate-containing drug products, Benzalkonium Chloride in Otozone Otic drops, and dissolution/drug release for tannate products. 3. **Failure to Investigate Discrepancies (21 CFR 211.192)**: Inadequate investigation of out-of-