OPS International Inc – FDA 483, Mar 21, 2013

The FDA Form 483 details numerous deficiencies at a facility producing sterile and injectable drug products. Key issues include the lack of validation for sterilization processes, particularly for oil-based products and those prepared from non-sterile ingredients like Progesterone, Estradiol Cypionate, Mitomycin, Alprostadil, Papaverine, and Phentolamine. Bioburden limits for non-sterile components are not established. Sterilization process parameters and load patterns for various products (e.g., Acetyl-D-Glucosamine with Chondroitin, Methylprednisolone Acetate) are unvalidated, and formula worksheets lack parameters.

The redacted used for sterilization is supplied with redacted not tested for endotoxin or sterility. Media fill simulations are inadequate, not simulating all aseptic operations, lyophilizer loading, or syringe filling. Aseptic techniques are deficient, with observations of torn gloves, exposed skin, infrequent glove sanitizing, hands passing over open vials, and technicians re-entering clean rooms without regowning. The pathway for transferring partially stoppered vials to the lyophilizer is not entirely HEPA-filtered.

Contamination prevention is lacking, with non-sterile Mitomycin API processed in the same ISO 5 hood as non-potent drugs. Environmental monitoring is insufficient, lacking daily active microbial air monitoring in the ISO 5 hood, daily fingertip monitoring, daily surface monitoring, and non-viable particle monitoring. Incubation conditions for monitoring samples are incorrect. No microbial