# FDA 483 - Central Admixture Pharmacy Services, Inc. - November 20, 2015

Source: https://www.keypedia.com/records/483/central-admixture-pharmacy-services-inc/4b65df4e-b118-495c-a6e1-769c9d1c917c

> FDA 483 for Central Admixture Pharmacy Services, Inc. on November 20, 2015. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Central Admixture Pharmacy Services, Inc.
- Inspection Date: 2015-11-20
- Product Type: Drugs
- Office Name: Philadelphia District Office
- Summary: This FDA Form 483 details multiple violations observed during an inspection of a sterile drug production facility.

**Facility and Operations:** The facility produces sterile drug products in ISO 5 and ISO 7 classified rooms.

**Violations and Observations:**

*   **Microbiological Contamination Prevention (21 CFR 211.42(c)(10)):**
    *   Employees in ISO 5 workstations had exposed eyebrows and facial skin.
    *   Dirt and grime were observed on equipment handles under an ISO 5 hood during production.
*   **Personnel Gowning (21 CFR 211.28(a)):**
    *   Employees were allowed to exit and re-enter the cleanroom suite for breaks without re-gowning, contrary to SOP 40000171.
*   **Contamination Prevention (21 CFR 211.42(b)):**
    *   A cleaning tool (b4) was left hanging on a trash can, used for cleaning before entering ISO 7 areas, and its usage times were not logged.
    *   Uncontrolled components were stored in the ISO 7 area near an ISO 5 workstation.
*   **Building Maintenance (21 CFR 211.58):**
    *   Paint chips and dark rust were present on hooks in ISO 5 workstations near sterile drug components and T

## Related Documents

- [STATE_REFERRAL_LETTER - 2015-11-09](https://www.keypedia.com/records/state_referral_letter/central-admixture-pharmacy-services-inc/fd1b4947-e38f-4e8c-b3ee-c92a70644551)

## Related Officers

- [Investigator](https://www.keypedia.com/people/anita-r-michael/b7699b1a-4157-477e-8226-2cfc906fc61d)

Company: https://www.keypedia.com/companies/central-admixture-pharmacy-services-inc/97e256d0-fc19-45ca-a85b-498a0a43d748

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8