Microbiological Contamination, Inadequate Records Cited at Bausch & Lomb Plant

An FDA inspection found microbiological contamination of drugs purporting to be sterile at a Bausch & Lomb manufacturing facility in Florida, according to a Form 483 handed to the company.

An eight-day inspection was conducted at the plant in February, and significant problems were found, including records of investigations into unexplained discrepancies that did not include conclusions or follow-up. A review of a lab report revealed that metal particles were observed in the course of the bottling process but were not mentioned or included in investigation reports.