Altaire Recalled Millions Of OTC Eye Drops, Halted Production After Repeat GMP Problems Found

“Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says. Warning submitted in March said falsifying data was found in making batch release decisions related to whether certain sterile ophthalmic drugs contained viable microorganisms.

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Falsifying data is among the manufacturing quality-control violations found at Altaire Pharmaceuticals Inc. in 2019 before the US firm began a sweeping recall of OTC eye drops and other sterile ophthalmic drug products, according to a regulatory warning.

The Food and Drug Administration’s inspection of the firm's facility in Aquebogue, NY, in March and April 2019 found some...