Maryland Specialty and Compounding Pharmacy – FDA 483, Dec 12, 2017

On December 12, 2017, the FDA issued a Form 483 to Professional Arts Pharmacy, a producer of non-sterile drug products, following an inspection from December 7-12, 2017. The inspection revealed three observations.

Observation 1 noted that drug products were released with strengths differing from their purported or represented potency. Examples included sub-potent Progesterone 100mg suppositories (human use, 76.4-84.6% potency), sub-potent Budesonide 1mg capsules (veterinary use, 84.2% potency), and super-potent Fluoxetine 30mg capsules (veterinary use, 113% potency). The firm's acceptable potency range is [(b)(4)].

Observation 2 detailed inadequate cleaning practices for highly potent or hazardous drugs, leading to potential cross-contamination. A pharmacy technician produced cortisone 5mg capsules, cleaned the surface with [(b)(4)], and then proceeded to produce theophylline 130mg capsules while wearing the same lab coat, which had contacted white powder from the previous production. The firm produces hormones, steroids, and hazardous drugs (e.g., chlorambucil). The non-dedicated apparatus is cleaned with soap and water for hazardous drugs/colored capsules, and routinely with [(b)(4)] or periodically with dish soap and water.

Observation 3 identified