Completing the Record.

WRP Asia Pacific, formerly Wembley Rubber Products, issued a response to our article in the May issue (page 8), giving an update on the FDA inspection of its facility in March 1997.

A fax from Vice President-QA/RA Y.W. Chow states that after Wembley got a warning letter from FDA on July 29, 1997, "there were substantial communications" between the firm and the agency "with the objective of resolving the issues at hand."

He said FDA reinspected the company in November 1997. The agency responded in December that the citations in the 483 were "adequately corrected and that WRP was operating in substantial compliance with GMP requirements." He said WRP products made after Sept. 12, 1997, would be removed from automatic detention via import alert No. 8904.

Inspection Monitor welcomes any firm to provide us with updates on inspections. In the case of foreign audits, it is sometimes difficult due to time differences and language barriers to obtain comments on our articles. We thank Wembley for bringing this news to our attention.

Management committed to lowering the microbial limit, the EIR stated.

* Rework procedures. SOPs for visual inspection had no instructions for handling vials in case they were dropped.

* Lab records. Lab test data sheets lacked the expected percent variance between duplicate results of protein analysis.

* Repeat testing. SOPs for the in-process testing lab did not explain when testing should be re-peated.

Despite the recurrent validation problems, there is no record of a second warning letter.

Swiss Red Cross Zentrallaboratorium, Bern, Switzerland, 8/5-8/97, Doc. 108660M, $5 plus retrieval.