FDA issues warning letter to Health Pharma for cGMP violations
Posted: 16 January 2020 | Joe Doherty (European Pharmaceutical Review) | No comments yet
An inspection at a manufacturing facility belonging to Health Pharma has revealed breaches of cGMP regulations, causing the FDA to send a warning letter.
The US Food and Drug Administration (FDA) has sent a warning letter to Health Pharma regarding its manufacturing site in New Jersey, US, after violations of current good manufacturing practice (cGMP) regulations were found.
The violations were identified after an inspection of the facility from 13 May to 3 June 2019, causing the products from the facility to be considered “adulterated.”
These included, but were not limited to:
- Failure to ensure that drug products are manufactured in compliance with cGMP and meet established specifications for identity, strength, quality and purity
- Incomplete information of batch production and control records
- Lack of adequate written procedures for production and process control designed to assure cGMP for drug products with no review from the company’s quality control unit
- Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength and quality as well as no validation of supplier quality.
The FDA has recommended that the company engage a quality consultant to assist the firm in meeting cGMP requirements.
A comprehensive assessment and remediation plan is now required by the FDA to ensure that the facility’s quality unit is given the authority and resources to effectively function. The company must discontinue shipments of drug batches to allow the quality unit to perform a proper, complete review that permits batch release. It must also provide a list of all the lots within distribution including historical and current stability data.
The violations listed in the letter must promptly be corrected by Health Pharma; the FDA has warned that failure to do so may results in legal action against the company and “withhold[ing] approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer until the above violations are corrected,” as stated in the letter.
