MedisourceRx – FDA 483, Sep 27, 2018

The FDA Form 483 details significant deficiencies at a drug manufacturing facility. The Quality Control Unit failed to investigate fiber particulates in Glutathione 200mg/mL in 30mL MDV commercial lots (MSRX1207, MSRX1189, MSRX1181) and media fill qualifications, despite numerous instances of particulates. A (b)(4) qualification study for (b)(4) compatibility with compounded formulations is also missing.

Personnel clothing was inappropriate, with a cleaning employee touching their sterile gown on the floor during donning. Aseptic processing areas exhibited cleaning and disinfection deficiencies: cleaning materials were not disinfected before transfer from ISO 8 to ISO 7 areas, and SOPs for cleaning lacked specific instructions on mop stroke area, cleaning direction, and detailed documentation for cleaning logs, disinfectant rotation, contact times, and cleaning agent lot/expiration dates. Disinfectant effectiveness studies were not completed.

Employee training records were deficient, lacking pass/fail specifications for gowning/handwashing competency audits. Personnel monitoring excursions (e.g., Rothia dentocariosa, Rothia mucilaginosa, Streptococcus australis) occurred, yet commercial production continued. Contract cleaning employees lacked training on critical SOPs before entering cleanrooms.

Control systems were deficient, allowing multiple ISO classified doors to remain open simultaneously. Media fill qualification procedures failed to demonstrate worst-case conditions, lacking documentation of maximum occupants and clear