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.
The facility could not provide raw data so the FDA investigators could assess the quality of its water system, and an employee said half the data generated over a year was lost.
The company also lacked data on sample weight, test methods, calculations performed and water monitoring data.
Lastly, the inspection found the water system was not properly designed, maintained and controlled to produce high-purity water.
The agency called on the firm to find the root cause of the missing data and to develop a CAPA plan that includes a risk assessment of how the existing system impacted product quality.