FDA WARNING_LETTER - Vinyas Innovative Technologies Pvt., Ltd. - August 14, 2014

On December 12, 2014, the FDA issued a Warning Letter to Vinyas Innovative Technologies Pvt., Ltd. following an August 14, 2014, inspection of their Mysore, India facility, which manufactures the ViScope device. The inspection revealed the ViScope is an adulterated device 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) and § 352(o).

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** The firm did not validate (b)(4) processes or establish operating parameters with statistical rationale. The response was inadequate, lacking evidence of proper validation or retrospective review of other processes. 2. **Failure to monitor and control validated process parameters (21 CFR 820.75(b)):** Procedures for monitoring and controlling process parameters were not established. The provided document lacked operational qualification data, tolerance ranges, and monitoring methods. 3. **Inadequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)):** The CAPA procedure failed to employ statistical