FDA 483 - Shertech Pharmacy- Piedmont - July 18, 2019

This FDA Form 483 document outlines several observations made during an inspection of a drug manufacturing facility. The firm produced drugs concurrently with construction in an adjacent area, lacking sufficient controls to prevent contamination of the production environment and product. The facility's design and/or operation were noted to permit poor flow of personnel and materials.

Observations related to aseptic processing included personnel touching surfaces outside the ISO 5 classified aseptic processing area with gloved hands and then engaging in aseptic processing without changing or sanitizing gloves. Additionally, personnel involved in aseptic processing were observed leaving and re-entering the cleanroom from non-classified areas without replacing gowning apparel. The facility also failed to use sporicidal agents in its cleanrooms and/or ISO 5 classified aseptic processing area.

Regarding documentation, the firm's records were deficient, lacking complete documentation of all data obtained during testing to ensure product meets release specifications. Furthermore, records associated with drug product components, containers, closures, labeling, production, control, and distribution, within their retention period, were not made readily available for authorized inspection.