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Pharmaceuticals / Inspections and Audits

FDA Warns Alabama Compounder Over Insanitary Conditions

Feb. 25, 2019

The FDA hit Triad Rx, a Daphne, Alabama compounding pharmacy, with a warning letter citing multiple instances of insanitary conditions.

The agency’s inspection, conducted from July 17-21, 2017, found 11 violations that caused the drug products to be adulterated, including ISO classified areas with equipment or surfaces that were visibly dirty and the use of non-sterile cleaning pads or wipes in ISO 5 areas.

The investigator found that personnel didn’t adhere to sanitation requirements. For example, employees were seen touching equipment or other surfaces outside of the ISO 5 area with gloved hands and then conducting aseptic processing in the cleanroom without changing or sanitizing the gloves. In addition, equipment used in aseptic processing wasn’t disinfected before entering the ISO 5 processing area, and the preparation and contact time of the sporicidal agent used for cleanrooms and ISO 5 areas was insufficient.

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