Indus Medicare Limited – FDA Warning Letter, Jan 23, 2020

The FDA issued a Warning Letter to a firm in Telangana, India, following an inspection from January 20-23, 2020. The inspection determined the firm manufactures Invigra male natural latex condoms, classified as devices. These devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish Medical Device Reporting (MDR) information (21 CFR Part 803).

Key QS violations included inadequate process validation (21 CFR 820.75(a)), insufficient acceptance procedures for in-process product (21 CFR 820.80(c)), failure to control device design (21 CFR 820.30(a)), inadequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), and lack of rework procedures for non-conforming product (21 CFR 820.90(b)(2)). Additionally, the firm failed to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17). The firm's response to the FDA 483 observations was deemed inadequate for all violations, lacking systemic corrective actions, retrospective reviews, and training plans.

Consequently, all products manufactured by the firm are subject to refusal of admission into the U.S. (detention without physical examination). The firm must provide a written response within fifteen business days detailing specific corrective actions, prevention plans, documentation, and a timetable for implementation to address the systemic problems. Failure to correct violations may also impact federal contracts and premarket approval applications.