Chinese API maker Sichuan Pharmaceutical finds itself on the stinger end of a warning letter just posted to the FDA website. The warning follows two attempts by the drugmaker after a June 2010 inspection to convince the agency it has its previous cross-contamination shortcoming back up to par.
It hasn't achieved that goal. And the FDA appears to imply that some serious consequences are now on the table. "In your response to this letter include your plans for decontamination, renovation, and reactivation (if appropriate) of your facility including the decontamination agent, decontamination plans, analytical methodology for environmental and product testing, and the data obtained to support the effectiveness of the decontamination plan," the letter says.
Inspectors saw the possibility of cross-contamination between adjacent workshops that produced different APIs. The agency also noted that the company lacked an adequate monitoring program.
The drugmaker had sent remediation responses to the FDA following the receipt of the Form 483 inspection report from the inspections in August and December. But they did not satisfy the FDA.
"Your firm has failed to conduct adequate assessment of the cross-contamination risks," the letter says.
- here's Warning Letter 320-11-019