At the end of January, the FDA inspected the company AllerQuest LLC, which operates the aseptic production of pharmaceuticals, including injectables, in its premises. The inspection revealed a number of deficiencies that queried the assurance of sufficient quality and sterility.
For example, the premises used did not meet the requirements defined in 21 CFR 211.42© for separate and defined zones for aseptic production areas. Zone A (ISO5) of the ampule filling area was, for instance, directly accessible through a double door from the uncontrolled area, whereby this door had large gaps which the manufacturer had tried to seal with adhesive tape. The aseptic processing line design was also inadequate. The production line had limited protection and there was a high risk of contamination from manual intervention and envorinmental air.
Since the company's response on 22 March announced the commitment of external advice, unfortunately insufficient supporting documentation was provided to evaluate the effectiveness of the corrective and preventive action (CAPA). While the company pointed out that all batches of its drug had passed the sterility tests for release, the FDA points out that a final product test alone is not sufficient to determine the sterility of all units, as contaminants are not distributed homogeneously.
That is why the FDA demands the following as from AllerQuest:
In addition, shortcomings in the area of environmental monitoring and personnel monitoring were also identified which were not sufficiently defined and implemented. Even in the event of deviations, no corresponding effective measures were taken, e.g.
Further information on this and other deficiencies identified can be found directly in the Warning Letter on cGMP deficiencies according to 21 CFR, parts 210 and 211.