FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation

 

After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations.

The FDA has hit Bausch & Lomb with a warning letter after inspectors flagged problems including the use of phones in the aseptic processing area.

FDA inspectors visited a Bausch & Lomb plant in Florida in March. Assessing the facility’s ability to make sterile prescription and over-the-counter drugs, the inspectors found fault with practices used to prevent contamination and concluded the site lacks an effective quality management system. Bausch & Lomb responded to the findings in April but has apparently failed to reassure the FDA sufficiently to prevent a warning letter, which was sent Sept. 4 and published on the agency’s website on Sept. 15.

Bausch & Lomb’s response to the findings showed a lack of commitment to implement significant design remediations, the FDA said. The agency ruled that the company’s response did not address how it will ensure adequate aseptic processing operations.

“The letter does not require us to halt operations or conduct a product recall, and we remain confident in the quality and safety of products manufactured there,” Bausch & Lomb said in a statement emailed to BioSpace on Wednesday. “We’ve invested significant resources in remediation and quality improvements at the facility and will continue to provide FDA with evidence of our completed corrective actions and their effectiveness.”

Bausch & Lomb’s Tampa site houses a 171,000-square-foot pharma R&D and manufacturing facility. The company disclosed in July that the FDA had issued an Official Action Indicated for the site the previous month. At the time, Bausch & Lomb requested a meeting with the FDA and a reinspection of the facility, saying it had fully completed all comprehensive corrective and preventive actions raised.

But the warning letter makes clear that the FDA disagrees. The letter focuses on two violations of the Federal Food, Drug, and Cosmetic Act. First, the FDA criticized Bausch & Lomb’s efforts to prevent contamination or mix-ups in aseptic processing areas.

Bausch & Lomb failed to sufficiently monitor significant locations, the FDA said, citing the use of phones in the aseptic processing area to make its case. Inspectors also found that media used in an environmental monitoring program were “inadequate to support growth of recovered contamination.”

From 2023 to 2025, the facility routinely recovered out-of-limit microorganisms from aseptic areas, the FDA said. The recovered microbes included microorganisms “frequently associated with water sources, suggesting a moisture-related contamination issue,” the agency added. The FDA accused Bausch & Lomb of continuing production without adequate actions to address persistent microbiological contamination.

The second violation identified by the FDA reflects the alleged failure to establish and follow appropriate written procedures for preventing microbiological contamination. Inspectors saw operators “repeatedly exhibiting poor aseptic practices during filling operations”—for example, by reaching over exposed bottles.

https://www.biospace.com/drug-delivery/fda-warning-letter-accuses-bausch-lomb-of-lacking-commitment-to-remediation