FDA 483 - Michigan Medicine - June 29, 2016

On June 29, 2016, the FDA issued a Form 483 to Stanley S. Kent, Chief Pharmacy Officer at the University of Michigan, a producer of sterile drug products located at 1500 E Medical Center Dr, Ann Arbor, MI. The inspection, conducted from June 6-29, 2016, identified eight observations.

Observation 1 noted inadequate investigations into multiple positive sterility test results for products like Bupivacaine, Phenylephrine, Calcium Gluconate, and Hydromorphone. Investigations failed to identify root causes, evaluate potential product/process impact, or implement sufficient corrective actions.

Observation 2 detailed inadequate aseptic practices and procedures. Issues included transferring items to ISO 5 areas without sanitization, placing non-sterile gauze in ISO 5 hoods, operators contacting ISO 5 items without re-sanitizing gloved hands, resting gloved hands/non-sterile gown sleeves on ISO 5 surfaces, and improper storage of sterile spray bottles. Smoke studies were also not performed under dynamic conditions.

Observation 3 cited deficiencies in aseptic processing area equipment and maintenance. This included cracks and seams in ISO 5 hood surfaces, unsecured ceiling tiles, unsealed gaps around sprinkler covers, surface damage on ceiling tiles, non-cleanable operator contact surfaces, damaged floor seams, unnecessary items in cleanrooms, and rust on a cleanroom refrigerator. HEPA filters in ISO 7 and