The FDA has had a long and troubled history with compounding pharmacies, which create tailor-made versions of doctor-prescribed drugs. Advocates say the FDA's crackdown on pharmacy quality has been draconian, at times, but sometimes those facilities bring it on themselves.
Auro Pharmacies operated a veritable house of horrors at its La Habra, California, outsourcing facility, with ants in the sterile production areas and visibly dirty work surfaces, FDA investigators found during an August 2018 inspection.
Those poor conditions could have produced supposedly sterile drugs that were "contaminated with filth," investigators said. The FDA knocked Auro with a 10-observation Form 483 in August, 2018 that led to a voluntary recall of all the pharmacy's affected drugs and a stoppage to all sterile production, investigators said.
In a letter posted online Wednesday, the FDA warned Auro that it would need to undergo a top-to-bottom reworking of its sanitary conditions prior to restarting production or simply give up compounding those drugs altogether.
During what was likely a long day for investigators, the FDA discovered ants in Auro's production area, including "an ant ... observed on the outer surface of an FDA investigator’s sterile hood cover."
Investigators also found unidentified "white and brown residue" on multiple production hoods, which the FDA tied to likely liquid stains.
Those sanitary flaws were only the tip of the iceberg for Auro, however. The FDA also noted that Auro had no drug approval applications on file with the agency, meaning the pharmacy may have violated federal law if it sold any of its products out of state.
In addition, Auro mislabeled its drugs' directions for self-diagnosis and treatment even though the drugs were only meant to be taken with a prescription.
Even worse for Auro, the FDA followed up its August 2018 look-in with another round of inspections in September of last year that turned up most of the same sanitary issues, including "filth" on the end of hood-cleaning wands, and cracked and scratched production hoods.
That inspection lead to a separate 11-observation Form 483 sent in October.
However, this isn't the FDA's first run-in with Auro. Back in 2016, the FDA sent the compounding pharmacy a separate warning letter blasting its La Habra facility's sanitary conditions, including one worker rubbing their gloved hands and elbows on one of the production hoods.
The FDA also cited Auro for the same labeling issues, saying the company wasn't receiving prescriptions for the drugs it was creating for patients.