Perrigo failure to follow SOPs, rethink broader GMP procedures draws FDA warning letter.
This article was originally published in The Tan Sheet
Executive Summary
PERRIGO FAILURE TO FOLLOW SOPs, RETHINK PROCEDURES DRAWS FDA WARNING LETTER sent to the Allegan, Mich.-based private label manufacturer on Sept. 23. The warning letter, from FDA's Detroit District Office, says there "appears to be a pattern of not following existing Standard Operating Procedures. Your systems have identified problems; however, the follow-up does not always determine the cause nor see resolution of the problem." Noting prior contact between FDA and the company wherein Perrigo proposed corrections to its Good Manufacturing Practices, the agency says "your representatives have been cautioned that all of the firm's Standard Operating Procedures should be evaluated, not only those cited."
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