FDA WARNING_LETTER - Hi-Tech Pharmacal Co., Inc. - December 03, 2009

An FDA inspection of Hi-Tech Pharmacal Co., Inc. from October 21 to December 3, 2009, revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, the firm manufactures and distributes an unapproved new drug, Paregoric Liquid, USP, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act, and misbranding it under section 502(f)(1).

Key CGMP violations include: 1. Failure to establish adequate laboratory control mechanisms, exemplified by releasing Prednisolone API (Lot 26910) despite out-of-specification (OOS) results for impurities and unsupported OOS investigation conclusions. 2. Lack of scientifically sound specifications and test procedures, such as failing to perform residual solvent testing for certain drug products, not drying or determining water content of in-house reference standards, and not confirming normality factors of commercially prepared volumetric solutions. 3. Failure to record and justify deviations from written specifications, like incorrect expiration dating for Riboflavin 5' Phosphate Sodium reference standard. 4. Inadequate validation of test methods for assay analysis of various vitamin drops and Urea Cream 40%, lacking characteristics like accuracy, robustness, and specificity, and insufficient chromatographic data.