Instituto Bioclon, S.A. de C.V. – FDA Warning Letter, Jan 23, 2014

The FDA conducted an inspection of Instituto Bioclon S.A. de C.V. from January 14-23, 2014, documenting significant deviations from current good manufacturing practice (CGMP) requirements in the manufacture of its licensed biological drug product Anascorp? and its intermediates. Violations cited include non-compliance with Section 501(a)(2)(B) of the FD&C Act, BLA requirements, and 21 CFR Parts 210 and 211. Key deficiencies involved failures to establish and follow procedures to prevent microbiological contamination (including inadequate environmental monitoring and media fill validation), investigate out-of-specification results, reject non-conforming products, establish adequate laboratory controls, ensure proper personnel and supervisory training, maintain adequate qualified personnel, prevent contamination/mix-ups in facility operations, establish production time limits, retain and inspect reserve samples, and control labeling. Additionally, issues with intermediate manufacturing included inadequate employee training, lack of hold time studies, insufficient inventory control, and cross-contamination risks due to shared gowning areas. The FDA found the firm's initial response insufficient and requested a meeting to discuss corrective actions. Failure to promptly correct these deviations may result in regulatory action, including license suspension or revocation, with federal agencies being advised of the Warning Letter.