FDA Completes Reinspection of Wyeth Manufacturing Site

Rockville, MD (Apr. 5)-The US Food and Drug Administration (FDA, www.fda.gov) concluded its reinspection of Wyeth’s (Madison, NJ, www.wyeth.com) manufacturing facility in Guayama, Puerto Rico. Conditions at the Guayama facility prompted a Warning Letter in May 2006.

The 2006 Warning Letter cited several violations of current good manufacturing practice (CGMP) regulations stated in 21 CFR Parts 210 and 211. One of the most prominent violations was the company’s failure to investigate unexplained discrepancies and out-of-specification results in batches of Triphasil 21 and 28 tablets as required under 21 CFR 211.192. A stability interval assay test for the tablets indicated an unknown peak at high levels, and subsequent tests confirmed the presence of the peak. FDA contends that Wyeth did not take any action against the affected lots of Triphasil or describe corrective or preventive measures the firm planned to take to prevent future peaks. The Warning Letter noted that between December 2003 and August 2005, 17 other incidents of unknown peaks were inadequately investigated.

FDA claimed that Wyeth violated 21 CFR 211.67(a) by failing to clean and maintain its packaging equipment, and the company also did not adequately inspect its packaging and labeling equipment as required under 21 CFR 211.130(e). In addition, Wyeth did not submit NDA Field Alert Reports in a timely manner in accordance with 21 CFR 314.81, and the company’s quality control unit did not review production records to ensure that no errors occurred or fully investigate errors that occurred during the manufacturing process as stated under 21 CFR 211.22(a). The full text of the Warning Letter can be accessed here.

Wyeth intends to respond to any observations issued by the FDA inspector no later than mid-April. In addition to being reinspected by FDA, the Guayama site underwent a CGMP inspection by representatives of the European Medicines Agency (EMEA, London, www.emea.eu.int) during the week of March 26, 2007, in which Wyeth received a positive evaluation of the site’s compliance status.