Five months after blocking the products of Prosana Distribuciones from the U.S., the FDA has issued a warning letter for the Mexican company.
The letter, which was issued December 18, follows an import alert for the company issued in August after the FDA found out that employees had not been testing APIs and admitted they had falsified some batch records for the OTC products it was shipping to the U.S.
The warning was the result of an inspection in March 2017 at the Mexico City facility and followed some back and forth from the company and the FDA about how Prosana was addressing the issues uncovered by investigators.
It said that Prosana never conducted even one test to make sure that the active ingredient going into its Bicaruvas Antacid Effervescent Powder—a product the FDA determined was unapproved—were safe and effective and couldn’t locate for inspectors the certificate of analysis.
During the inspection, the firm’s management said that operators “made up” yield results for steps such as weighing and filling, as well as for label reconciliation because there were no established calculations for determining yields.
The agency suggested the Mexican company get a consultant and ordered it to report back about how it was going to handle quality control for things like testing for microbial contamination and testing APIs. It ordered the company to investigate the “extent of the inaccuracies in data records.”
Neozene is a full-service CRO that partners with its clients to provide compliant quality solutions for all areas of Quality. This includes both Quality Programs and Quality Services. Quality Services are the provision of expert assistance at all levels of quality to ensure successful completion of all Quality initiatives in all levels of the organization.