FDA 483 - ideal specialty apothecary, inc. - August 31, 2017

An FDA inspection of Ideal Specialty Apothecary Inc., operating as Ideal Pharmacy, was conducted on multiple dates between June 19, 2017, and August 31, 2017. The inspection, which covered the production of sterile and non-sterile drug products, resulted in several observations listed on a Form FDA 483, indicating deviations from manufacturing quality standards.

Key issues included a negative pressure gradient in the ISO-5 aseptic filling area, raising concerns about potential contamination of sterile products like Medroxyprogesterone Acetate Injection Suspension. Environmental monitoring revealed the presence of various microorganisms, including Bacillus and Staphylococcus. Cleaning practices were cited for using non-sterile pads and sterile wipes lacking established expiration dates after opening. Furthermore, the ISO-5 environment certification and microbiological testing were not conducted under dynamic, routine operational conditions. Media fill studies, designed to simulate aseptic processing, were found inadequate, differing significantly from actual production in terms of lot size, equipment usage, and sterilization methods. The facility also exhibited an inadequate air handling design in the production room, with HEPA filters and returns located on the ceiling, potentially leading to poor air circulation. Lastly, condensation was observed dripping from HEPA units onto equipment, with one filter showing a visible yellow mark.

Ideal Pharmacy is expected to address these significant deficiencies to ensure compliance with good manufacturing practices and safeguard the quality and sterility of its drug products.