Centurion Laboratories Private Limited – FDA Warning Letter, Oct 26, 2018

The FDA issued a Warning Letter to Centurion Laboratories Private Limited following an inspection from October 22-26, 2018, at their drug manufacturing facility in Manjusar, Gujarat, India. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Torn stability study data, analytical testing sheets, and release forms were found in trash bags, some showing out-of-specification (OOS) results that were officially recorded as within specification. Blank stability study forms were also pre-signed and approved. The firm's explanation was deemed inadequate, and a retrospective evaluation of all affected records and a CAPA plan are required. 2. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Laboratory equipment used for batch release and stability testing lacked appropriate controls. Shared usernames/passwords for high-performance chromatography systems and full system administrator privileges for analysts allowed data modification/deletion. The firm's response was inadequate as it did not assess data integrity compromise. An assessment of all CGMP computer systems and assurance of continuous audit trail enablement are required. 3. **Failure to Follow Cleaning and Maintenance Procedures (21 CFR 211