Bi-Coastal Pharma International

Warning LetterOpen

Mr. Ralph Massa, Jr. President and CEO Bi-Coastal Pharma International 1161 Broad St Ste 216 Shrewsbury , NJ 07702-4362 United StatesFEI 3013263547Issued Jun 30, 2022Office of Pharmaceutical Quality Operations Division I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013263547.

Violations4

Issue DateJun 30, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Bi-Coastal Pharma International
Location: Mr. Ralph Massa, Jr. President and CEO Bi-Coastal Pharma International 1161 Broad St Ste 216 Shrewsbury , NJ 07702-4362 United States
FEI Number: 3013263547
Country: United States
Issue Date: June 30, 2022
Issuing Office: Office of Pharmaceutical Quality Operations Division I
Product Type: Drugs
Status: Open

Summary

Bi-Coastal Pharma International was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs, rendering their products adulterated. The company failed to establish and follow adequate written procedures for handling drug product complaints and, specifically, failed to adequately investigate a June 2020 complaint regarding an adverse reaction to Chlordiazepoxide Hydrochloride and Clidinium Bromide 5 mg/2.5 mg without initiating the required manufacturing and packaging evaluation. The violations were documented during an FDA inspection conducted from December 15, 2021, to January 14, 2022, at the company's Shrewsbury, New Jersey facility.

Bi-Coastal Pharma International FDA Warning Letter, June 30, 2022