FDA WARNING_LETTER - Kumar Organic Products Limited - November 14, 2019

The FDA issued a Warning Letter to Kumar Organic Products Limited following an inspection from November 11-14, 2019, at their facility in Vadodara, Gujarat, India. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, specifically concerning the manufacturing of an active pharmaceutical ingredient (API) (b)(4), which is an in-process material for an over-the-counter topical drug product. Consequently, the drug product is deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Equipment Design and Maintenance (21 CFR 211.63):** The (b)(4) system used in manufacturing was not adequately designed, maintained, or monitored. Issues included turning off the system when not in use, outdated (b)(4) (last changed in August 2014), active leaks, and inadequate cleaning procedures for storage tanks. Microbial sampling intervals were insufficient, and the firm's response regarding bioburden control was deemed inadequate. 2. **Failure to Test Components and Validate Supplier Analyses (21 CFR 211.84(d)(1) and (2)):** The firm failed to test incoming components, such as (b)(4), for identity. Specifically, a technical grade of (b)(4) was used without testing