FDA inspection observations in late July of evidence of mold contamination in a Class 100 aseptic suite and inadequate controls in place to prevent it led to a warning letter to Wrexham, U.K.-based CP Pharmaceuticals at the end of October.
In issuing the letter, Office of Compliance (OC) Division of Manufacturing and Product Quality Director Richard Friedman explained that the firm’s written responses submitted in September to the July 29 FDA 483 had not been considered, in accord with the agency’s policy announced in August 2009 that the responses need to be within 15 days to impact the warning letter decision-making process (a link to the policy is provided below).
Friedman informed CP that the 483 responses would be evaluated as a follow-up to the warning letter, along with the other written material that is provided.
Mold contamination and the related aseptic controls were also at issue in a warning letter to India-based Claris Pharmaceuticals issued just two days after the CP letter (see the IPQ “In the News” November 30 companion story).
The two letters highlight the attention being given by FDA investigators to contamination control in sterile product manufacturing facilities located abroad and where the red flags lie.
[An analysis of the aseptic control issues drawing FDA concern at CP Pharmaceuticals is provided for subscribers here. Non-subscribers may purchase the full story along with the Claris companion story for $75 by contacting Jonathan Trethowan at Jonathan@ipq.org. To subscribe to IPQ, click here.]