Pfizer's Visine aseptic filling operations draw FDA warning letter.
This article was originally published in The Tan Sheet
Executive Summary
PFIZER VISINE ASEPTIC FILLING OPERATIONS are the subject of an FDA warning letter sent to the firm in December. As a follow-up to an inspection of Pfizer's Parsippany, N.J. facilities in early November, the warning letter questions the company's particulate monitoring procedures, investigation of out-of-specification results of the sterile filling equipment, and sterile filling production records related to Visine ophthalmic solutions. The letter is signed by Matthew Lewis, director of FDA's Newark District Office.
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