# FDA 483 - Compound Preferred LLC - March 01, 2017

Source: https://www.keypedia.com/records/483/compound-preferred-llc/2cb56dff-6dd8-4e94-9589-fdc271871fa9

> FDA 483 for Compound Preferred LLC on March 01, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Compound Preferred LLC
- Inspection Date: 2017-03-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details significant deficiencies at a facility producing sterile and non-sterile drug products, including Eylea 2mg/0.05mL injection.

**Key Violations and Observations:**

*   **Microbiological Contamination Prevention (Observation 1):** Procedures are not established, written, or followed. This includes using a non-UHEPA vacuum in an ISO 7 cleanroom, failure to perform media fills for production operators (105 batches produced without required media fills), and improper storage of previously worn sterile gloves.
*   **Environmental Monitoring Deficiencies (Observation 2):** The environmental monitoring (EM) procedure (SOP 08-004) is inadequate, relying on third-party certifiers every six months. Viable and non-viable air sampling, surface sampling in the ISO 5 laminar flow hood (LFH), and daily personnel monitoring are not performed during sterile drug production. Additionally, the ISO 5 LFH and adjacent ISO-classified areas were not recertified after expiration on 12/31/16, leading to 19 lots of sterile drug product being produced without proper certification.
*   **Aseptic Area Cleaning and Disinfection (Observation 4):** Non-sterile wipes and non-sterile 70% isopropyl alcohol (IPA) are used to clean critical surfaces. Drug containers and components are placed into the ISO 5 LFH

## Related Documents

- [483_RESPONSE - 2017-03-01](https://www.keypedia.com/records/483_response/compound-preferred-llc/0913ec67-3f8d-46ce-96f1-8444c3be3e62)
- [WARNING_LETTER - 2017-03-01](https://www.keypedia.com/records/warning_letter/compound-preferred-llc/d7d4a707-3d72-4915-bda4-bc79715216e7)
- [483 - 2019-08-01](https://www.keypedia.com/records/483/compound-preferred-llc/5d40fe4e-e577-4b81-9059-578d4c7cd1a3)
- [483 - 2019-08-01](https://www.keypedia.com/records/483/compound-preferred-llc/8b6d495f-8b79-495b-8ade-3ca5e95ce9a6)
- [483 - 2021-12-17](https://www.keypedia.com/records/483/compound-preferred-llc/6e16267f-c12e-46a1-87a5-454c861549fe)

## Related Officers

- [Gary C. Pecic](https://www.keypedia.com/people/gary-c-pecic/37cf1f4d-6b1c-4be6-8adb-89cf685f5022)
- [Division Director at CDRH/OPEQ/Office of Regulatory Programs](https://www.keypedia.com/people/lisa-t-michel/b14c9205-185f-4eaa-bf3c-3bf5bbc50a06)
- [Senior Director, Precision Medicine and Innovative Strategies](https://www.keypedia.com/people/tracy-k-li/dce1757a-bb2a-462c-868c-bae77168a764)
- [Gerard P. DeLeon](https://www.keypedia.com/people/gerard-p-deleon/f9942ff3-948b-4c8b-b65f-fdcc9ab9a3cc)

Company: https://www.keypedia.com/companies/compound-preferred-llc/0137c1b7-e3ba-45ff-9fda-c53b21b0b857

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