# FDA 483 - Allied Pharmacy Products. Inc. - January 10, 2023

Source: https://www.globalkeysolutions.net/records/483/allied-pharmacy-products-inc/806816b2-46c3-4096-8831-9f08763c0128

> FDA 483 for Allied Pharmacy Products. Inc. on January 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allied Pharmacy Products. Inc.
- Inspection Date: 2023-01-10
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Allied Pharmacy Products, Inc. in Delray Beach, FL, a specification developer, identified two significant issues. The firm failed to adequately document corrective and preventive action activities for an investigation and lacked established procedures for design transfer to a contract manufacturer. These observations indicate deficiencies in the firm's quality system regarding CAPA and design control.

## Related Documents

- [483 - 2019-03-13](https://www.globalkeysolutions.net/records/483/allied-pharmacy-products-inc/c1b7bfa8-3a76-4b82-9f12-cbab32835af2)

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/allied-pharmacy-products-inc/f77359cc-f73e-4fad-917a-f40629ed8e2d

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6