FDA EIR - Amneal Complex Products Research LLC - April 18, 2018

An FDA pre-approval inspection of Kashiv Pharma, LLC, located in Bridgewater, NJ, was conducted from April 3 to April 18, 2018. This inspection, carried out under Compliance Program 7346.832, focused on assessing the company's readiness for commercial manufacturing, adherence to submitted applications, and data integrity for specific drug products.

The inspection led to the issuance of an FDA Form 483 with two primary observations. Firstly, the company failed to thoroughly investigate out-of-specification (OOS) results, specifically regarding unidentified peaks and contaminants found in HPLC chromatograms during a hold time study (Investigation KI-16-017). This deficiency indicated a lack of comprehensive root cause analysis, contrary to regulatory expectations (21 CFR 211.192). Secondly, the Quality Control unit lacked written procedures for the Acceptance Quality Limit (AQL) inspection performed post-packaging of tablets, a violation of 21 CFR 211.22(d).

Additionally, discussions with management highlighted other issues, including insufficient documentation for 100% visual label inspections in batch records, the presence of non-applicable steps in manufacturing batch records, and the omission of preventative maintenance schedules in standard operating procedures for certain laboratory equipment. Kashiv Pharma committed to providing a formal response to the FDA 483 observations within 15 business days, outlining their corrective actions.