FDA 483 - Medaus, Inc. - March 11, 2016

The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including injectables like DMSO and Testosterone Cypionate.

Environmental monitoring in aseptic processing areas is deficient. The ISO 7 environment exceeded action levels for spore-forming and gram-positive organisms in August 2015 (50 cfu) and February 2016 (12 cfu) without root cause determination or corrective action. Surface and air monitoring is not performed daily in the ISO 5 laminar flow hood (LFH), and personnel fingertip monitoring is infrequent. HEPA filters in the ISO 7 area lack leak testing, and pressure differentials between the ante room (ISO 8) and non-classified warehouse are not monitored due to a missing gauge. Environmental certification does not occur under dynamic conditions.

Sterilization process validation is lacking. Media fills do not represent challenging conditions (e.g., quantities, container sizes). Sterilization equipment for media bottles, vials, and pellets is not qualified, calibrated, or performed. Sterile injectables are produced from non-sterile materials using an unvalidated method. Documentation of sterilization parameters is incomplete, often only stating "pass."

Personnel movement from ISO 7 to ISO 5 (LFH) occurs without decontamination, crossing a red tape line that is only tape and conceals contamination.

A written stability testing program is absent. Beyond-use dates (6 months for most, 30/90 days for others