Incomplete cGMP records, active ingredient testing and quality unit shortcomings prompted the FDA to issue a warning letter to Bingbing Pharmaceuticals, an OTC drugmaker in Hubei, China.
The firm, which was placed on an import alert in August, failed to maintain manufacturing records, raw material and finished product testing records and other records for OTC products made at its Wuhan facility, the agency said. The company said some documents and product samples were lost during the May 2018 move of its manufacturing facility from Wuhan to Hubei.
FDA investigators found that the company failed to keep complete and accurate records of complaint investigations. For two investigations of batches made at the Wuhan facility, the company claimed it evaluated reserve samples and found no deficiencies, despite previously admitting all of the reserve samples were lost for batches made at the Wuhan plant.
It also failed to test for active ingredients in certain products, releasing the untested OTC drug products to the U.S. market, the agency said.