Drug manufacturer Degasa did not adequately test its products or include all necessary data in laboratory records, according to a warning letter from the FDA.
FDA officials investigated the company’s Mexico City facility last September and found it did not conduct proper microbial testing. For example, the company’s antiseptic products are indicated for preparation of skin before surgery and preventing infections in minor cuts, but the facility did not test its products for microbial attributes, including lack of microbial contamination.
To address this finding, the agency called on Degasa to develop an action plan to test retain samples of all batches within the U.S. market still within expiry, and to provide microbiological test methods and finished product release specifications for each of its drug products. The agency also requested validation studies for each microbiological testing method it used.