FDA Warns Bausch & Lomb Over Tampa Eye-Med Plant Contamination
The FDA has issued a warning letter to Bausch & Lomb over contamination concerns at its Tampa, Florida, facility that makes prescription and over-the-counter eye medications.
Federal regulators have sent Bausch & Lomb a warning letter over contamination concerns at its Tampa, Florida, manufacturing site. The facility produces both prescription and over-the-counter eye medications, according to the Fierce Pharma report on the letter.
The letter marks a formal escalation following the agency's concerns about the plant's conditions. Because this article relies on a single source, there are no conflicting reports to weigh, and the specific contaminants or the timing of the FDA's inspection have not been disclosed.
The warning letter is a regulatory step that can lead to further enforcement if the company fails to address the issues. Bausch & Lomb has not yet publicly responded, per the report.
More in Medicine & Biotech
Ebola Vaccine Trial Launches in DR Congo Outbreak Zone
Health workers in DR Congo have begun testing whether a vaccine designed for a different Ebola strain can protect against the current outbreak.
Beacon Gene Therapy for Rare Vision Loss Succeeds in Pivotal Trial
A pivotal trial of Beacon Therapeutics' gene therapy for X-linked retinitis pigmentosa improved visual acuity, clearing the path toward an FDA submission.
Alkermes orexin agonist shows early promise for ADHD
Early-stage data suggest Alkermes' orexin agonist could expand the drug class beyond sleep disorders into ADHD.
Telix to Buy ITM for $1.65B, Challenging Novartis in Radiopharma
The acquisition gives Telix a late-stage pipeline and supply network that could compete with Novartis' Lutathera.