The current good manufacturing practices (cGMP) problems at the facility, one of several active pharmaceutical ingredient (API) plants Ampac operates in North America, were discovered during a Food and Drug Administration (FDA) inspection in February.
While Ampac replied to the agency in March, a letter published on the FDA's site last week, described the response as lacking “sufficient corrective actions.”
Foremost among the FDA’s concerns is that the fine chemicals producer has not detailed the “new procedures” it has developed to manage and quarantine rejected API batches.
This comment refers to the detection, during the inspection, of an unmarked returned drum of the oncology API temozolomide among batches of the compound that had been labeled as acceptable for release.
The FDA said that: “Your response is inadequate because you have not addressed how you will manage returned APIs,” reminding the firm that “it is your responsibility to ensure that returned APIs are properly identified and quarantined separately from material approved for distribution.”
Inter-batch cleaning need clarification
The FDA also highlighted cleaning procedures as an area requiring clarification, citing a January incident where cleaning was not carried out between the production of two different APIs, despite records indicating that it had been done.
In its original response to the inspection, Ampac described the event was an "isolated incident” that was not indicative of the effectiveness of its manufacturing facility audit procedures.
However, in its latest letter the FDA deemed this reaction as insufficient because the firm had not described how it will ensure cleaning is performed before batch production begins in the future.
The agency gave Ampac 15 days to respond to the letter which was issued on June 25. The Las Vegas-headquartered fine chemicals manufacturer did not respond to in-pharmatechnologist’s request for additional information on how its efforts to correct the problems are progressing.