# FDA 483 - Michigan Medicine - June 29, 2016

Source: https://www.keypedia.com/records/483/michigan-medicine/70ec50c4-f72e-47a1-8d10-129f917bab87

> FDA 483 for Michigan Medicine on June 29, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Michigan Medicine
- Inspection Date: 2016-06-29
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: 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

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## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)
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Company: https://www.keypedia.com/companies/michigan-medicine/c3c12a4a-a8c6-468f-9cfc-571dc0f08095

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03