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Regulatory Focus™ > News Articles > 2020 > 1 > Warning Letters: FDA Targets Chinese, New Jersey Drugmakers

Warning Letters: FDA Targets Chinese, New Jersey Drugmakers

Posted 14 January 2020 | By Zachary Brennan 

Warning Letters: FDA Targets Chinese, New Jersey Drugmakers

The US Food and Drug Administration (FDA) on Tuesday released two warning letters recently sent to China-based contract manufacturer Huaian Zongheng Bio-Tech Co. and New Jersey-based drug manufacturer Health Pharma USA for GMP violations.

For Huaian Zongheng Bio-Tech Co., which was placed on import alert last November, FDA inspectors said the firm released over-the-counter drugs without conducting identity or strength testing for each active ingredient.

The firm also failed to test incoming components used to manufacture its drug products to determine their identity.

In addition, the company failed to adequately validate the manufacturing processes for its drug products, the agency said following a five-day inspection last July. 

“You performed process validation for only one of your drug products; however, you manufacture numerous drug products with different formulations and with multiple active pharmaceutical ingredients,” the warning letter dated 9 January said. FDA also noted that the manufacturer did not provide sufficient process performance qualification protocols or studies for each formulation of its drug products.

Health Pharma USA

For Health Pharma USA, FDA inspectors, following a visit to the Rahway, New Jersey site last May and June, said the firm’s quality unit (QU) lacks the appropriate oversight of its drug manufacturing operations.

“Your firm lacked adequate written procedures for many QU (i.e., quality assurance) functions, for example, review and approval of executed batch records, batch release, investigation of out-of-specification (OOS) results, cleaning, equipment qualification, stability testing, gowning, and sample control,” the letter dated 18 December 2019 said.

FDA also found that the firm released aspirin and acetaminophen tablets before release testing was approved by a contract laboratory. The agency also said the firm’s batch records are inadequate and missing critical production information as records for a type of aspirin “lacked information on the entire enteric coating process” and “did not specify how long bulk material should be blended.”

In addition, Health Pharma failed to routinely perform identity testing for ingredients “such as aspirin DC90, microcrystalline cellulose 102, and acetaminophen DC90. Furthermore, you did not adequately qualify your component suppliers to establish the reliability of their certificates of analysis,” FDA said.

Huaian Zongheng Bio-Tech Co., Ltd

Health Pharma USA LLC

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