FDA 483 - Jajco, Inc. DBA Anchor Drugs Pharmacy - June 03, 2016

An FDA inspection on May 20, 2016, revealed significant deficiencies at a drug manufacturing facility. The facility's compounding pharmacist was observed performing aseptic operations for sterile drug product Atropine 0.01% Solution, Lot #05/20/2016:1031, with exposed skin on the face and neck, and using non-sterile gowning components (disposable lab coat, dust mask, street reading glasses, hair net). Bare hands were also exposed inside the ISO 5 Laminar Flow Hood after removing sterile gloves.

The environmental and personnel monitoring program was found deficient, lacking assurance of adequate control in production areas. Procedures for preventing microbiological contamination were not established or followed, including the absence of smoke studies for the ISO 5 Laminar Flow Hood and validation studies for sterile products like Phenol 5% in Cottonseed Oil and Glycerin 100% Ophthalmic Solution. Environmental and personnel monitoring plates were not producing reliable results, and media fills from January 2013 to present did not simulate actual processing or adhere to SOP 2.030 Sterile Compounding Personnel Qualification. Contact times for sporicidal and disinfectant agents were not specified in written procedures.

The firm failed to thoroughly investigate unexplained discrepancies, including a recalled sterile drug product (Cyclopentolate/Phenylephrine/Tropicamide/Proparacaine ½.5/1.0/5% ophthalmic