# FDA 483 - Exquisite Corporation - April 26, 2023

Source: https://www.keypedia.com/records/483/exquisite-corporation/17dcb0ad-d2dc-49a6-820f-28ed7a1c5723

> FDA 483 for Exquisite Corporation on April 26, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exquisite Corporation
- Inspection Date: 2023-04-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Exquisite Corporation, a contract drug manufacturer in Baldwin Park, CA, was cited for significant deficiencies in its quality control unit, stability program, production and process controls, and equipment maintenance. The inspection revealed a lack of defined responsibilities for the quality unit, inadequate testing and validation practices, and insanitary conditions. These issues indicate a serious breakdown in the firm's pharmaceutical quality system.

## Related Documents

- [483 - 2024-08-01](https://www.keypedia.com/records/483/exquisite-corporation/7adbc9a0-7cf9-4056-88b8-7d277f5fd230)

## Related Officers

- [investigator](https://www.keypedia.com/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)

Company: https://www.keypedia.com/companies/exquisite-corporation/cf4dd029-0549-4ddb-b1f4-83e7a2559f7c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6