Quality Oversight Failures Found at New Jersey Facility

January 17, 2020

FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.

FDA sent a warning letter, dated Dec. 18, 2019, to Health Pharma USA that detailed violations of current good manufacturing practices (CGMP) at the company’s Rahway, NJ facility. The agency conducted an inspection of the facility from May 13 to June 3, 2019 during which inspectors found that the company’s quality unit (QU) was inadequate.

Specifically, the agency stated in the letter that the company lacked adequate written procedures for quality assurance functions and was shipping product before it was properly reviewed by the quality unit. The company failed to perform sampling, testing, supplier qualification, batch record control, and deviation investigations, according to FDA.

FDA asked the company to provide an assessment and remediation plan to ensure the effective function of its quality unit. The agency also asked that the company “commit to discontinue your practice of allowing shipment of a drug batch and describe how you will ensure the QU performs a proper, complete review that permits batch release.”

The letter also stated that the company failed to include complete information in batch production and control records and failed to establish adequate written procedures for production and process control. In addition, components were not tested for identity and conformity with written specifications for purity, strength, and quality.

“Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer … You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity,” the agency stated.

Source: FDA