# FDA 483 - ABC Pharmaceuticals - Unknown Date

Source: https://www.keypedia.com/records/483/abc-pharmaceuticals/ee3e1027-7dbf-44b5-bf68-32a204281486

> FDA 483 for ABC Pharmaceuticals on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABC Pharmaceuticals
- 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 inspected by the FDA. The inspection revealed significant deficiencies in cell bank testing, manufacturing process control, quality unit oversight of outsourced activities, yield determination, and written procedures for quality control. These issues indicate a lack of robust quality systems and process control, potentially impacting product quality and regulatory compliance.

## Related Documents

- [483 - 2021-07-02](https://www.keypedia.com/records/483/abc-pharmaceuticals/a3372419-edca-457a-b93e-82b5ce1c8775)
- [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 - 2022-07-15](https://www.keypedia.com/records/483/abc-pharmaceuticals/412558cb-dfa8-4c93-bacb-ab95e25f6cc4)
- [483 - 2025-02-27](https://www.keypedia.com/records/483/abc-pharmaceuticals/de22bb22-e4de-4192-adbc-cc975ed8c2f1)

## Related Officers

- [Joao Pedras-Vasconcelos](https://www.keypedia.com/people/joao-pedras-vasconcelos/143cf25e-168d-43da-adc8-9107c4f01b44)
- [Senior Consumer Safety Officer](https://www.keypedia.com/people/carla-j-lundi/a10ed698-54fe-4635-a766-8c31f501dfb2)

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