# FDA 483 - Michigan Medicine - December 14, 2018

Source: https://www.keypedia.com/records/483/michigan-medicine/364d1ce8-177e-4f11-ab69-64c50d6b51c0

> FDA 483 for Michigan Medicine on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Michigan Medicine
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Michigan Medicine, a producer of sterile and non-sterile drug products in Ann Arbor, MI, was inspected by the FDA and cited for multiple deficiencies in aseptic processing. Observations included inadequate disinfection of materials, poor personnel practices, facility design issues affecting material flow, and insufficient use and documentation of sporicidal agents. These issues indicate a risk of contamination in their sterile drug production.

## Related Documents

- [483 - 2016-06-29](https://www.keypedia.com/records/483/michigan-medicine/70ec50c4-f72e-47a1-8d10-129f917bab87)
- [483 - 2018-12-14](https://www.keypedia.com/records/483/michigan-medicine/ae801547-c1ff-4e82-ac96-15004453a3be)
- [145 - 2019-06-13](https://www.keypedia.com/records/145/michigan-medicine/382b8553-a25f-43c9-a00a-f6bd87d690cd)
- [STATE_REFERRAL_LETTER - 2018-12-03](https://www.keypedia.com/records/state_referral_letter/michigan-medicine/19aa97c0-9d16-448a-a774-161e9e821d60)

## Related Officers

- [Emily J. Orban](https://www.keypedia.com/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)

Company: https://www.keypedia.com/companies/michigan-medicine/c3c12a4a-a8c6-468f-9cfc-571dc0f08095

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0