# FDA 483 - Bi-Coastal Pharma International - January 14, 2022

Source: https://www.globalkeysolutions.net/records/483/bi-coastal-pharma-international/92a91ec8-8497-4ee5-a51b-3d26004ca5e9

> FDA 483 for Bi-Coastal Pharma International on January 14, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bi-Coastal Pharma International
- Inspection Date: 2022-01-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Bi-Coastal Pharma International, an own label distributor in Shrewsbury, NJ, was cited for significant deficiencies in its quality control unit, particularly concerning oversight of contract manufacturers and adherence to GMP documentation practices. The inspection revealed a lack of written procedures for quality oversight, an absence of a stability testing program, and inadequate complaint handling and investigation processes. Furthermore, the firm's QA Manager was found to lack the necessary experience and training for their assigned responsibilities.

## Related Documents

- [483 - 2020-09-14](https://www.globalkeysolutions.net/records/483/bi-coastal-pharma-international/14aa73d5-06a1-4bb1-b620-6b1305d741d4)
- [WARNING_LETTER - 2022-01-14](https://www.globalkeysolutions.net/records/warning_letter/bi-coastal-pharma-international/9d69b93a-a4bd-41ab-bcb4-264b50e2661a)

## Related Officers

- [Rose L. Jean-Mary](https://www.globalkeysolutions.net/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Investigator](https://www.globalkeysolutions.net/people/guerlain-ulysse/aeef6f71-43b1-4116-b563-8bb3f2966d6a)

Company: https://www.globalkeysolutions.net/companies/bi-coastal-pharma-international/38b9fd58-5145-4f23-9c94-1ba900477ef2

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