# FDA 483 - Accra-Pac, Inc. - November 05, 2021

Source: https://www.keypedia.com/records/483/accra-pac-inc/3d578ff9-5099-4ae4-89a4-921d6532ec98

> FDA 483 for Accra-Pac, Inc. on November 05, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accra-Pac, Inc.
- Inspection Date: 2021-11-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Accra Pac, Inc. in Elkhart, IN, was inspected by the FDA, resulting in three observations. The inspection revealed significant deficiencies in process validation for medical devices, inadequate evaluation of out-of-calibration equipment, and failures in their corrective and preventive action system. These issues indicate a lack of robust quality system controls.

## Related Documents

- [483 - 2022-09-02](https://www.keypedia.com/records/483/accra-pac-inc/af323154-8aed-4986-b022-04ded0b71a97)
- [WARNING_LETTER - 2022-09-02](https://www.keypedia.com/records/warning_letter/accra-pac-inc/cc8a2bcb-eaca-4f91-bdbf-f5d8c7d94d22)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/accra-pac-inc/fe89d000-bb66-4348-9b5a-2e86dd5117eb

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0