FDA 483 - Purformance Wellness Pharmacy LLC dba Seven Cells - December 09, 2022

This FDA Form 483 documents observations made during an inspection of a facility producing hazardous drugs. The primary issues identified relate to inadequate cleaning procedures and observed non-microbial contamination, leading to potential cross-contamination.

Specifically, the firm failed to use a strong oxidizer capable of deactivating hazardous drug products (testosterone, progesterone, estriol, and/or estradiol) on work surfaces and non-dedicated, shared equipment. Furthermore, the firm has not established that its current cleaning agent, (b)(4), is adequate to remove drug product residues from shared equipment used for these hazardous drugs.

Non-microbial contamination was observed in the production area. On December 1, 2022, an unknown white powder-like substance was found on two separate (b)(4) capsule machines. These machines, used for hazardous drug products including progesterone, had last been used on November 7, 2022, for (b)(4) 25mg capsules and November 29, 2022, for Ivermectin 18mg capsules, with capsule production also occurring on the day of observation. Additionally, a white jar with a yellowish, greasy residue was found in a cabinet storing clean, non-dedicated equipment for topical drug products (creams and gels) containing hazardous drug substances like testosterone, progesterone, estriol, and/or estradiol.