# FDA 483 - Medivera Compounding Pharmacy - June 19, 2017

Source: https://www.keypedia.com/records/483/medivera-compounding-pharmacy/ce02ac44-894a-49d5-a1bd-be13b09f1ae4

> FDA 483 for Medivera Compounding Pharmacy on June 19, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medivera Compounding Pharmacy
- Inspection Date: 2017-06-19
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: On June 19, 2017, the FDA issued a Form 483 to Diversified Pharmacy Inc., a producer of sterile and non-sterile drug products located at 6054 Livernois Road, Troy, MI 48098. The inspection, conducted from June 5-8, 14, and 19, 2017, identified three observations.

Observation 1 noted that ISO-classified areas had difficult-to-clean, particle-generating, or visibly dirty equipment or surfaces. Specifically, a large patch of white residue was observed on the HEPA filter grate of an ISO5 hood during aseptic processing of methylcobalamin 1000 mg on June 6, 2017.

Observation 2 stated that ISO5 classified areas were not certified under representative dynamic conditions. Smoke studies performed in the ISO5 laminar flow hoods did not accurately represent aseptic processing practices, as the dynamic smoke study videos showed an operator standing (b)(4), which was not representative of observed aseptic operations, such as the processing of Bimix (lot #06072017@28) on June 7, 2017, which included a (b)(4) that could affect laminar air flow.

Observation 3 detailed that hazardous drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. Glassware and stainless

## Related Documents

- [483_RESPONSE - 2014-11-13](https://www.keypedia.com/records/483_response/medivera-compounding-pharmacy/aadba832-a93b-48f0-a698-11e1d9fd2208)
- [483 - 2014-11-13](https://www.keypedia.com/records/483/medivera-compounding-pharmacy/ba737f08-9870-44a5-b506-fc426365d693)
- [STATE_REFERRAL_LETTER - 2017-06-05](https://www.keypedia.com/records/state_referral_letter/medivera-compounding-pharmacy/efb8e039-9c72-4b0e-b874-7adce8a0bc4e)
- [145 - 2018-11-01](https://www.keypedia.com/records/145/medivera-compounding-pharmacy/c0d7ae9d-b3e2-42de-9e28-cd8db012a173)

## Related Officers

- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.keypedia.com/companies/medivera-compounding-pharmacy/85d05a2e-2537-48e6-ae57-70debd2c31ec

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