# FDA 483 - Accra-Pac, Inc. - September 02, 2022

Source: https://www.globalkeysolutions.net/records/483/accra-pac-inc/af323154-8aed-4986-b022-04ded0b71a97

> FDA 483 for Accra-Pac, Inc. on September 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Accra-Pac, Inc.
- Inspection Date: 2022-09-02
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Accra-Pac, Inc. dba Voyant Beauty, LLC in Elkhart, IN, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into product contamination and manufacturing failures, insufficient laboratory controls and data integrity, and a quality unit that does not fully follow its responsibilities and procedures. These issues indicate a systemic breakdown in quality management and control processes.

## Related Documents

- [483 - 2021-11-05](https://www.globalkeysolutions.net/records/483/accra-pac-inc/3d578ff9-5099-4ae4-89a4-921d6532ec98)
- [WARNING_LETTER - 2022-09-02](https://www.globalkeysolutions.net/records/warning_letter/accra-pac-inc/cc8a2bcb-eaca-4f91-bdbf-f5d8c7d94d22)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/logan-m-ebeling/546c6a0d-664e-4189-b02b-2f8c1c05a640)
- [Paranthaman Senthamarai Kannan](https://www.globalkeysolutions.net/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)
- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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

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