API manufacturer Sichuan Pharmaceutical Co. in Pengzhou, Sichuan, China received a warning letter in early September, 2011, based on issues that FDA investigators found during a June, 2010 inspection related to potential cross-contamination risks.
The agency cited the firm for manufacturing products in a facility that had not been appropriately cleaned and decontaminated after previous production of other products, and for manufacturing products in adjacent “workshops” with inadequate controls to ensure that cross-contamination did not take place. Sichuan’s August and December 2010’s responses to the 483 were deemed “inadequate.”
Although the products of concern are redacted from the warning letter, on Sichuan’s website the firm lists both oral and injectable penicillins as products it produces.
The letter directs the Chinese firm in its response to “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.”