# FDA 483 - A.P. Deauville, LLC - May 02, 2019

Source: https://www.globalkeysolutions.net/records/483/ap-deauville-llc/a8188453-e199-46bc-a56a-5cdb7ccb7ab0

> FDA 483 for A.P. Deauville, LLC on May 02, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A.P. Deauville, LLC
- Inspection Date: 2019-05-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: A.P. Deauville, LLC was cited for numerous deficiencies across its manufacturing, quality control, and laboratory operations. The inspection revealed significant issues including inadequate complaint handling, lack of process validation, poor equipment cleaning, and insufficient stability testing. Furthermore, the firm demonstrated a lack of employee training, incomplete laboratory records, uncalibrated instruments, and unsanitary facility conditions, indicating a systemic failure to adhere to good manufacturing practices.

## Related Documents

- [WARNING_LETTER - 2019-05-02](https://www.globalkeysolutions.net/records/warning_letter/ap-deauville-llc/77a9b17a-e7f3-452f-95fd-805d120e21ed)
- [483 - 2025-01-23](https://www.globalkeysolutions.net/records/483/ap-deauville-llc/fc7ab569-1e05-4ec6-863d-602f581f5401)

## Related Officers

- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.globalkeysolutions.net/companies/ap-deauville-llc/10e0fa49-4dd3-41be-93f3-0f046918839c

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248