# FDA 483 - Wedgewood Village Pharmacy, LLC - February 11, 2013

Source: https://www.keypedia.com/records/483/wedgewood-village-pharmacy-llc/354a115c-2852-460e-9bfc-0082af794a79

> FDA 483 for Wedgewood Village Pharmacy, LLC on February 11, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wedgewood Village Pharmacy, LLC
- Inspection Date: 2013-02-11
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA inspection of a facility compounding human and veterinary sterile drugs revealed multiple critical deficiencies across personnel practices, environmental controls, quality systems, and manufacturing processes.

**Personnel and Environmental Control Issues:**
*   **Aseptic Technique Violations:** Observed items (IV seals, IV bags) hanging in the ISO-5 horizontal laminar flow (HLF) hood, potentially blocking unidirectional airflow. A technician was seen leaning into the ISO-5 HLF hood directly over open containers, exiting the ISO-6 room multiple times during operations, and manipulating paper/pen with gloved hands without re-sanitizing before returning to the hood.
*   **Inadequate Gowning:** Gowning procedures left neck and feet/shoes exposed. Technicians were observed touching sterile coveralls to the ground during donning.
*   **Contamination Risks:** Personal items (cell phone, headphones) were brought into cleanrooms and touched critical surfaces.
*   **Lack of Sanitization:** Materials were not routinely sanitized immediately before entering ISO-6 rooms, ISO-5 HLF hoods, or ISO-5 biosafety cabinets.
*   **Documentation Failure:** A product leak during sterile filling was not documented in the batch log.
*   **Gowning Area Deficiencies:** No mirrors were present in ISO-7 gowning areas to ensure proper bouffant cap donning.

**Quality System and Manufacturing Deficiencies:**
*   **Lack of Sterility/Endotoxin Testing:** Sterile veterinary

## Related Documents

- [483_RESPONSE - 2015-09-30](https://www.keypedia.com/records/483_response/wedgewood-village-pharmacy-llc/89cbc59b-aba4-4e29-91ff-bfeaf873536a)
- [483 - 2022-03-24](https://www.keypedia.com/records/483/wedgewood-village-pharmacy-llc/57d11aab-1a1f-41e8-81d3-023bc714582b)
- [483 - 2015-09-29](https://www.keypedia.com/records/483/wedgewood-village-pharmacy-llc/14c9b9f5-15ed-463b-b0d5-99aa133e6b2d)
- [WARNING_LETTER - 2013-02-11](https://www.keypedia.com/records/warning_letter/wedgewood-village-pharmacy-llc/36f5a620-e433-45cd-84b4-17f043bc67f3)
- [WARNING_LETTER_RESPONSE - Unknown Date](https://www.keypedia.com/records/warning_letter_response/wedgewood-village-pharmacy-llc/9041bf02-f949-4ee0-8153-f9dd3c66eb0c)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/thomas-e-friel/205f23ee-8648-46d1-8485-11977a27e8e4)
- [Senior Compliance Officer](https://www.keypedia.com/people/barbara-wilimczyk-macri/36eda42e-09b6-4364-a000-c5cd8ddb70ee)
- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)
- [Investigator ](https://www.keypedia.com/people/juanita-p-versace/dca6c7fb-62ac-4b06-9c77-dbf52fc83422)

Company: https://www.keypedia.com/companies/wedgewood-village-pharmacy-llc/06cf5b50-fc20-475b-8be4-11a41985491e

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