# FDA 483 - Specialty Medicine Compounding Pharmacy, P.C. - November 05, 2013

Source: https://www.keypedia.com/records/483/specialty-medicine-compounding-pharmacy-pc/b96c486b-4466-4798-9710-6fa3513ec063

> FDA 483 for Specialty Medicine Compounding Pharmacy, P.C. on November 05, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Medicine Compounding Pharmacy, P.C.
- Inspection Date: 2013-11-05
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: The FDA Form 483 details numerous deficiencies at a facility producing sterile injectable drug products, including Dextrose 50% and Methylcobalamin UDP PF 25mg/mL.

Key violations include:
*   **Aseptic Processing:** Procedures to prevent microbiological contamination are not established or followed. Process simulations (media fills) are inadequate, not reflecting worst-case conditions. Manual aseptic operations, such as filling 25 open vials in an ISO 5 hood and multi-day bulk solution transfers, pose contamination risks.
*   **Environmental & Personnel Monitoring:** The program is deficient, lacking routine personnel monitoring (every shift/multiple locations), passive/active viable air monitoring during production, and adequate surface monitoring frequency. Non-viable particulate monitoring is not performed routinely.
*   **Facility Controls:** Air pattern analyses (smoke studies) for ISO 5 hoods are not performed under dynamic conditions, and no video is maintained. Air pattern analysis for the ISO 7 buffer room is absent. HEPA filter integrity testing for ISO 7 cleanroom filters (installed 11/01/2013) has not been performed. Pressure differentials between ISO 5 hoods and the ISO 7 cleanroom are not continuously monitored.
*   **Gowning & Materials:** Gowning components (hair covers, masks, Tyvek suit) are not sterile, leaving exposed skin. Storage conditions and clean hold times for sterilized containers, closures, and

## Related Documents

- [WARNING_LETTER - 2013-11-05](https://www.keypedia.com/records/warning_letter/specialty-medicine-compounding-pharmacy-pc/545666fd-bac9-417f-8449-d410a5bc44be)

## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)

Company: https://www.keypedia.com/companies/specialty-medicine-compounding-pharmacy-pc/4afe1151-2bbe-4fb3-8757-edda1bda051c

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