July 10 FDA Warning Letter Review
This past week two warning letters to 503B outsourcing facilities were posted to the FDA website.
In one of the warning letters, the outsourcing facility compounded drugs using raw material not on the 503B bulks list, failed to include all drugs compounded in the prior 6-months, and failed to report an adverse event within the required time period.
The second warning letter identified more typical observations including:
The latter warning letter illustrates some fairly common observations within 503B’s. It is up to the firm to determine what is required to meet cGMPs and then to perform testing to demonstrate that the firm (facility, equipment, people, materials) can meet those expectations. This may include hold times for sterile wipes, or depyrogenated glassware, or sterilization. This may require the firm to evaluate which operations performed in the ISO 5 production area is most challenging (and of course to document this risk approach) and use media fills to demonstrate the firm can successfully operate under these conditions. This also requires the firm to perform critical airflow visualization under dynamic conditions – in a previous warning letter/Form 483 the FDA identified a firm had an operator moving their arms around “to simulate” dynamic operations within the ISO 5 space – clearly this doesn’t pass the test.
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