# FDA 483 - Bi-Coastal Pharma International - September 14, 2020

Source: https://www.keypedia.com/records/483/bi-coastal-pharma-international/14aa73d5-06a1-4bb1-b620-6b1305d741d4

> FDA 483 for Bi-Coastal Pharma International on September 14, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bi-Coastal Pharma International
- Inspection Date: 2020-09-14
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Bi-Coastal Pharma International, an own label distributor/marketer in Shrewsbury, NJ, was inspected by the FDA from September 8-14, 2020. The inspection revealed a significant deficiency related to the lack of written procedures for handling post-marketing adverse drug experiences. This indicates a serious gap in their pharmacovigilance system.

## Related Documents

- [483 - 2022-01-14](https://www.keypedia.com/records/483/bi-coastal-pharma-international/92a91ec8-8497-4ee5-a51b-3d26004ca5e9)
- [WARNING_LETTER - 2022-01-14](https://www.keypedia.com/records/warning_letter/bi-coastal-pharma-international/9d69b93a-a4bd-41ab-bcb4-264b50e2661a)

## Related Officers

- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

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

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