> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations in Bi-Coastal Pharma Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-bi-coastal-pharma-inspection/
- Published: 2022-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:53:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152360

A 13/15/21-1/14/22 FDA inspection at the Bi-Coastal Pharma International drug manufacturing facility in Shrewsbury, NJ, found significant violations of current good manufacturing practice regulations for finished drugs. A 6/30 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bi-coastal-pharma-international-628196-06302022?ref=fdaweb.com) says specific violations were:

- failing to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation;
- failing to establish an adequate quality unit and failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and
- failing to ensure that each person responsible for supervising the manufacture, processing, packing, or holding of a drug product has the education, training, or experience, or any combination thereof, to perform assigned functions in such a manner as to assure that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.

The letter says the firm’s responses to the inspection observations were inadequate. FDA strongly recommends that Bi-Coastal engage a qualified consultant to assist it in meeting CGMP requirements. FDA also reminds the firm that it is responsible for the quality of its drugs regardless of agreements in place with contract manufacturers.

Bi-Coastal was told to correct violations promptly and respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.