FDAnews Drug Daily Bulletin

Wyeth to Answer FDA Reinspection Findings in Guayama Facility

April 16, 2007

Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company's Guayama, Puerto Rico, manufacturing facility, the firm announced.

The agency cited Wyeth last year for current good manufacturing practice (cGMP) violations at the Guayama site in a warning letter.

The company "intends to respond in writing to the observations issued by the FDA inspector no later than mid-April and then will seek to continue its discussions with the agency regarding the overall compliance status of the facility," Wyeth said.

Wyeth also said the discrepancies cited by the agency in the reinspection involved sampling and testing procedures, as well as review of lab and process investigations. The agency conducted the reinspection between late January and late March.

Resolution of the manufacturing issues is, in part, holding up approval of the antidepressant Pristiq, according to an FDA approvable letter Wyeth received for the Effexor follow-on earlier this year.

However, Wyeth noted that a European Medicines Agency (EMEA) inspection of the Guayama site last month found "no critical or major observations." The EMEA gave the site a positive evaluation for compliance with cGMPs, the firm said.