Perrigo failure to follow SOPs, rethink broader GMPs draws FDA warning letter.
This article was originally published in The Rose Sheet
Executive Summary
PERRIGO FAILURE TO FOLLOW SOPs, REVISE PROCEDURES DRAWS FDA WARNING LETTER regarding the private label manufacturer's Montague, Mich.-based manufacturing facility. In a Sept. 23 warning letter from FDA's Detroit district office, the agency 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." Referring to correspondence between the agency and the company wherein Allegan, Mich.-based Perrigo proposed corrections to the Good Manufacturing Practices citations, FDA warns that "all of the firm's Standard Operating Procedures should be evaluated, not only those cited."