The FDA has issued a warning letter to Bausch & Lomb over contamination concerns at its Tampa, Florida, facility that produces prescription and over-the-counter eye medications.
The rebuke from the U.S. regulatory agency comes after Bausch & Lomb received the lesser wrist-slap of a Form 483 following an inspection of the site between March 12 and March 20 of this year.
The company was cited for two major violations in the new letter posted to the FDA’s website this week and dated Sept. 4.
Inspectors found that from 2023 to 2025, the facility routinely recovered microorganisms in an aseptic production area that were out-of-limit with regulatory guidelines.
Those included Serratia marcescens and Stenotrophomonas maltophilia, which are associated with water sources and suggest a “a moisture-related contamination” problem, the agency said.
“You continued [redacted product] drug production without adequate corrective action and preventive action measures to address the persistent microbiological contamination in your ISO 5 environments that posed a risk to product sterility,” the FDA said.
The inspection also found design deficiencies in the facility’s access barrier system line, with the FDA noting that "basic design deficiencies and excessive recoveries of microorganisms from ISO 5 areas indicate that there is significant inherent contamination risk in your current operation."
Bausch & Lomb was also cited by the FDA for not following guidelines designed to prevent microbial contamination of drug products considered to be sterile.
The FDA specifically chided the Bausch & Lomb facility for its improper cleanroom behavior and poor aseptic technique, flagging multiple infractions during filling operations, such as operators reaching over exposed bottles to remove ones that were jammed, failing to disinfect before handling sterile supplies and more.
In light of the FDA's concerns, the regulator said that the Bausch & Lomb site "does not operate an effective quality system" in line with current manufacturing standards.
"Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements," the FDA advised in its letter, adding that Bausch & Lomb should promptly arrange a meeting with the agency after submitting its response.