# FDA 483 - ABC Pharmaceuticals - July 15, 2022

Source: https://www.keypedia.com/records/483/abc-pharmaceuticals/412558cb-dfa8-4c93-bacb-ab95e25f6cc4

> FDA 483 for ABC Pharmaceuticals on July 15, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABC Pharmaceuticals
- Inspection Date: 2022-07-15
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Revance Therapeutics, Inc. in Newark, CA, a drug substance and drug product manufacturer, was cited for three observations during an FDA inspection. The observations included failures in deviation reporting for an equipment leak, inadequate standard operating procedures leading to bioburden contamination, and incomplete documentation regarding cell bank storage facilities in their eCTD submission. These issues indicate deficiencies in quality system controls and documentation practices.

## Related Documents

- [483 - 2021-07-02](https://www.keypedia.com/records/483/abc-pharmaceuticals/a3372419-edca-457a-b93e-82b5ce1c8775)
- [483 - Unknown Date](https://www.keypedia.com/records/483/abc-pharmaceuticals/ee3e1027-7dbf-44b5-bf68-32a204281486)
- [483 - 2022-07-15](https://www.keypedia.com/records/483/abc-pharmaceuticals/5e82fb2d-00bb-4edb-a1a8-b12961b9f735)
- [EIR - 2022-07-15](https://www.keypedia.com/records/eir/abc-pharmaceuticals/bef7cdec-4f04-471f-8958-dceea9a5a092)
- [483 - 2025-02-27](https://www.keypedia.com/records/483/abc-pharmaceuticals/de22bb22-e4de-4192-adbc-cc975ed8c2f1)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/patricia-f-hughes-troost/11f80c43-380b-47a5-a389-1bad9093fd65)
- [Virginia A. Carroll](https://www.keypedia.com/people/virginia-a-carroll/180e8c1a-1712-4701-9399-9758573ef8d8)
- [Sarah A. Johnson](https://www.keypedia.com/people/sarah-a-johnson/bb59c0e2-87ab-4958-8d33-463382ab7937)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd