# FDA 483 - ABC Pharmaceuticals - February 27, 2025

Source: https://www.globalkeysolutions.net/records/483/abc-pharmaceuticals/de22bb22-e4de-4192-adbc-cc975ed8c2f1

> FDA 483 for ABC Pharmaceuticals on February 27, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABC Pharmaceuticals
- Inspection Date: 2025-02-27
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: Revance Therapeutics Inc. in Newark, CA, was inspected by the FDA from February 19-27, 2025. The inspection revealed a significant deficiency in laboratory controls, specifically regarding bacterial endotoxin testing procedures. The firm's SOP lacked instructions for sample mixing, and samples were improperly collected and stored, indicating a failure to ensure product quality and purity.

## Related Documents

- [483 - 2021-07-02](https://www.globalkeysolutions.net/records/483/abc-pharmaceuticals/a3372419-edca-457a-b93e-82b5ce1c8775)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/abc-pharmaceuticals/ee3e1027-7dbf-44b5-bf68-32a204281486)
- [483 - 2022-07-15](https://www.globalkeysolutions.net/records/483/abc-pharmaceuticals/5e82fb2d-00bb-4edb-a1a8-b12961b9f735)
- [EIR - 2022-07-15](https://www.globalkeysolutions.net/records/eir/abc-pharmaceuticals/bef7cdec-4f04-471f-8958-dceea9a5a092)
- [483 - 2022-07-15](https://www.globalkeysolutions.net/records/483/abc-pharmaceuticals/412558cb-dfa8-4c93-bacb-ab95e25f6cc4)

## Related Officers

- [Philip F. Istafanos](https://www.globalkeysolutions.net/people/philip-f-istafanos/c2fcfe52-1070-4551-bffc-f8bcfad5b30b)
- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/abc-pharmaceuticals/f3ef5d92-bea9-4e9d-9c91-f31bd703d6a8

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df