The US Food and Drug Administration (FDA) has issued a warning letter to Health Pharma regarding its manufacturing site in New Jersey, US, after violations of current good manufacturing practice (cGMP) regulations were observed.
The violations were recognized after an inspection of the facility from 13 May to 3 June 2019, causing the products from the facility to be contemplated “adulterated.”
The FDA has suggested that the company engage a quality consultant to aid the firm in meeting requirements of cGMP.
A comprehensive evaluation and remediation plan is now needed by the FDA to ensure that the facility’s quality unit is given the authority and resources to function effectively.
The company must terminate shipments of drug batches to permit the quality unit to perform a proper, complete review that allows batch release. It must also give a list of all the lots within distribution involving historical and current stability data.
Letter stated that the violations given in the letter must promptly be corrected by Health Pharma; the FDA has alerted 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.
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