FDA WARNING_LETTER - BIO LAB-ST. JOSEPH CORP - August 27, 2014

On August 6-27, 2014, an FDA inspection of BioLab-St. Joseph Corp. in Bayamon, P.R., revealed that the firm's microbiology culture media devices were adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Current Good Manufacturing Practice (CGMP) requirements. The firm's September 16, 2014, response to the FDA 483 was deemed inadequate.

Violations included: A. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), specifically lacking analysis of all quality data sources and presentation of significant CAPA information for management review. B. Inadequate process validation for sterilization and bag sealing (21 CFR 820.75(a)), with insufficient documentation and uncompleted validation activities. C. Failure to establish and maintain purchasing control procedures (21 CFR 820.50) to ensure product and service conformity. D. Failure to establish and maintain procedures for incoming product acceptance and documentation of results (21 CFR 820.80(b)). E. Failure to maintain records of complaint investigations (21 CFR 820.198(e)), with inadequate investigation scope.