FDA 483 - Option Care - August 06, 2015

This FDA Form 483 document details observations made during an inspection of a drug manufacturing facility. The facility's buildings, used for manufacturing, processing, packing, or holding drug products, were found not to be maintained in a clean and sanitary condition, and were not free of infestation by rodents, birds, insects, and other vermin.

Observations related to personnel and procedures include: * Protective apparel was not worn as necessary to protect drug products from contamination. * Procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not followed.

Regarding aseptic processing areas and quality systems, several deficiencies were noted: * The system for monitoring environmental conditions in aseptic processing areas was deficient. * Systems for maintaining any equipment used to control aseptic conditions in aseptic processing areas were deficient. * There was no written testing program designed to assess the stability characteristics of drug products.

These observations indicate issues with facility maintenance, personnel practices, environmental control, equipment maintenance in aseptic areas, and the absence of a formal stability testing program, all of which are critical for ensuring drug product quality and safety.