CDER Warns Chinese, Indian Manufacturers

Regulatory NewsRegulatory News | 27 August 2019 |  By 

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released two warning letters sent recently to India-based active pharmaceutical ingredient (API) manufacturer CTX Lifesciences Private Ltd and China-based drug manufacturer Ningbo Pulisi Daily Chemical Products Co.

Following a six-day inspection at CTX Lifesciences, FDA found that the firm did not ensure that the water used for parenteral grade APIs was suitable for its intended use. For example, FDA said that although the firm was aware that its non-sterile APIs are intended for sterile injectable drug product manufacturing, CTX failed to monitor and control the water used in certain “rinse steps for endotoxins.”

The agency also found that the firm invalidated an out-of-specification (OOS) related substances test result for certain API batches listed in a pending drug application without scientific justification. And the firm did not adequately investigate all potential causes of the unknown impurity.

“Until you correct all deviations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer,” the letter adds.

Meanwhile, the letter sent to China’s Ningbo Pulisi, which was placed on import alert in June and produces a foaming acne scrub, shampoo and hand sanitizer, among other over-the-counter (OTC) drug products, cited the company’s failure to test the products for their active ingredients.

“For example, you did not test drug products Halsa Anti-Dandruff Shampoo and Oil Free Acne Wash for their labelled active ingredients zinc pyrithione and salicylic acid, respectively, prior to release,” FDA said. “Your firm also lacked adequate testing for critical microbial attributes (e.g., absence of objectionable microorganisms).”
In addition, Ningo failed to adequately test incoming raw materials, including APIs and other components, for identity, purity, strength and quality.

“You used raw materials, including active ingredients, for drug manufacturing only after evaluating materials for appearance and smell,” FDA investigators said following a four-day inspection last February.

AmEx Pharmacy/Pacifico National

In addition to the two warning letters, FDA also requested a recall recently of all purportedly sterile drug products from a Florida-based facility of Pacifico National (also known as AmEx Pharmacy).

FDA said the firm received complaints related to patients experiencing eye issues, such as floaters and inflammation, although the company’s director of quality operations informed FDA investigators that the complaints have not been investigated. Some of the complaints involved Avastin products.

“FDA has determined that due to the lack of sterility assurance in producing purportedly sterile products…these products represent a serious health hazhard that outweighs the potential, if any, of a drug shortage,” the agency said in a letter to the company.

CTX Lifesciences Private Ltd.

Ningbo Pulisi Daily Chemical Products Co., Ltd

Letter to AmEx Pharmacy/Pacifico National


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