FDA WARNING_LETTER - Ohm Laboratories, Inc. - August 12, 2009

The FDA issued a Warning Letter to Ohm Laboratories, Inc. following a July-August 2009 inspection, citing significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Parts 210 and 211). These deficiencies render their drug products adulterated under Section 501(a)(2)(B) of the Act. Key CGMP issues included inadequate investigations into batch failures and OOS results (21 CFR § 211.192), failure to comply with and establish an adequate stability program (21 CFR § 211.166), and insufficient laboratory control mechanisms and documentation (21 CFR § 211.160(a)). The firm also lacked scientifically sound specifications (21 CFR § 211.160(b)), appropriate computer system controls (21 CFR § 211.68(b)), written process validation procedures (21 CFR § 211.110(a)), adequate qualified personnel (21 CFR § 211.25(c)), and equipment calibration (21 CFR § 211.68(a)). Additionally, Post Marketing Violations included failing to report distributed drug quantities in annual reports (21 CFR § 314.81(b)(2)(ii)) and not submitting timely NDA-Field Alert Reports (21 CFR § 314.81(b)(1)(ii)). The firm was also manufacturing and distributing an unapproved new prescription drug, violating sections 301(d) and 505(a) of the Act. The firm's initial response was deemed insufficient. Prompt corrective actions are required within fifteen working days to prevent legal action, including seizure and injunction, and potential impact on approvals. The FDA highlighted similar violations at other Ranbaxy facilities, urging a comprehensive global assessment.