# FDA 483 - CMC Enterprise Pharmacy - March 22, 2019

Source: https://www.keypedia.com/records/483/cmc-enterprise-pharmacy/8e8b03b0-4301-40ac-8302-14098a4ea538

> FDA 483 for CMC Enterprise Pharmacy on March 22, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMC Enterprise Pharmacy
- Inspection Date: 2019-03-22
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspection of the facility revealed multiple deficiencies in aseptic processing and quality control.

**Facility and Operations:**
The ISO 5 classified aseptic processing areas contained difficult-to-clean, particle-generating, and visibly dirty equipment and surfaces. This included drywall, power strip ledges, open outlets, computer peripherals, taped paper towels, binders, office supplies, anti-fatigue mats, crumbling drywall, peeling paint, paper, and rust on HEPA filter covers, IV bag racks, table/cart legs, and office chairs. A white residue was also observed on various surfaces.

**Violations and Observations:**
1.  **Aseptic Area Cleanliness:** ISO 5 areas had difficult-to-clean, particle-generating, and dirty surfaces (e.g., drywall, peeling paint, rust, office supplies).
2.  **Air Quality Control:** Facility design allowed lower-classified air into the ISO 5 sterile production area due to simultaneous opening of doors to the gowning room and ISO 5 area, causing repeated pressure reversals during sterile drug production.
3.  **Personnel and Material Flow:** The gowning room was inadequate for gowning and supply transfer, leading to personnel disregarding the line of demarcation and stepping over it without changing shoe covers.
4.  **Material Disinfection:** IV bags were not individually sanitized; instead, they were piled and only the outermost surfaces were sprayed before entering the ISO 5 area.
5.

## Related Documents

- [WARNING_LETTER - 2019-03-22](https://www.keypedia.com/records/warning_letter/cmc-enterprise-pharmacy/b17a631d-c10c-472a-a6f8-4b1decd3bce3)
- [145 - 2020-07-17](https://www.keypedia.com/records/145/cmc-enterprise-pharmacy/3e8fcd99-7a52-42d2-a2e2-fcd586f938aa)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rachael-l-cook/294a8276-4e31-4d9f-8f2d-6c8f08cefd06)
- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)

Company: https://www.keypedia.com/companies/cmc-enterprise-pharmacy/282431f0-ce0c-42b9-bbb8-e60c1f909eec

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c