Vista Pharmaceuticals Limited – FDA Warning Letter, Sep 23, 2016

The FDA issued a Warning Letter to Vista Pharmaceuticals Limited following a September 19-23, 2016, inspection of their drug manufacturing facility in India, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211). This renders their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Equipment Maintenance (21 CFR 211.67(a))**: The firm failed to properly clean and maintain equipment. Investigators observed holes and corrosion in equipment used for manufacturing various tablets, including isoxsuprine hydrochloride USP, 20 mg tablets. A prior complaint of metal embedded in tablets was not adequately investigated regarding equipment condition. The firm's response was inadequate for not including a retrospective review of affected products. 2. **Process Validation (21 CFR 211.100(a))**: The firm admitted to not performing process validation for isoxsuprine hydrochloride USP, 20 mg tablets, despite distributing numerous batches to the U.S. The response was inadequate for not outlining a validation plan or a retrospective risk assessment for distributed batches.

Additionally, the firm's isoxsuprine hydrochloride USP, 20 mg tablets (NDC 61971-065) were deemed