Bausch & Lomb Inspection FDA-483 Out

FDA has just released the FDA-483 that was issued at the conclusion of a 2/8-2/25 inspection at Bausch & Lomb’s facility in Tampa, FL. Specific violations noted on the form included: 

•          failing to include conclusions and follow-up in written records of investigations into unexplained discrepancies;
•          failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
•          failing to maintain at appropriate intervals equipment and utensils to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product; and
•          failing to establish control procedures that monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.