The FDA issued a warning letter to Prosana Distribuciones in Mexico City for serious GMP violations and for producing an adulterated drug product.
In a March inspection, the agency found that two batches of the firm’s product, Bicaruvas antacid effervescent powder, were distributed before certificates of analysis were obtained from a third-party testing laboratory.
The facility lacked adequate written procedures to ensure stable drug manufacturing operations and drug quality. The FDA investigators found the firm had not validated its manufacturing processes or performed process qualification studies, and did not have master batch records for each batch size. Three batches were found to contain five times the amount of calcium carbonate stated on the product label.
In addition, the firm failed to test the identity of incoming ingredients. Analyses from suppliers were not confirmed to be reliable and the firm sometimes accepted raw materials with no COAs. The inspection also revealed that operators at the facility had “made up” test results in batch records for processing stages like weighing, filling and label reconciliation.