CDRH and CDER Send Warning Letters to Six Asian Companies

Regulatory NewsRegulatory News | 14 February 2017 |  By 

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

The most recent letter, sent from FDA’s Center for Drug Evaluation and Research (CDER) to Bangalore, India-based active pharmaceutical ingredient (API) manufacturer Resonance Laboratories on 3 February, following a four-day inspection last May, says investigators found that the company had failed to demonstrate that its water system is suitable for cleaning equipment.

“After obtaining failing cleaning verification results, you repeated cleaning until you obtained passing verification results,” the letter says. “Your firm failed to investigate recurring cleaning procedure ineffectiveness and did not remediate the deficient procedures.” 

Another warning sent to Japan-based Sato Pharmaceutical on 2 February includes violations related to monitoring environmental conditions in the site’s aseptic processing areas, as well as its failure to perform smoke studies under “at rest” and “dynamic” conditions to evaluate air flow characteristics of its open Restricted Access Barrier System.

FDA recommends that Sato engage with a consultant to assist it in meeting CGMP requirements.

Another warning letter sent by CDER to China-based Zhejiang Bangli Medical Products Co. on 26 January included violations for failing to test incoming active pharmaceutical ingredients or other components used in manufacturing patches to determine their identity, purity and potency.

FDA laboratory analysis also showed that samples of the company’s product “were sub-potent for the labeled active ingredient, containing an average potency of 69.0% of the label claim.”

Similarly, China-based Ausmetics Daily Chemicals received a warning letter sent 31 January with violations including the fact that the firm only tested three batches released in 2015 for identity and strength, and two batches for microbiological quality.

Ausmetics also “accepted and used active raw materials in your drug products based only on their appearance and odor,” the letter says.

Taiwan-based blood glucose meter manufacturer Broadmaster Biotech received a Center for Devices and Radiological Health (CDRH) warning letter sent 4 October 2016 after investigators found that of 233 complaints received from January 2016 through April 2016, 86 were for issue codes that the firm does not routinely review and evaluate.

CDRH also sent a warning letter to China-based Hubei Hongkang Protective Products Co. on 15 September for failing to allow FDA to complete its inspection.

Hubei Hongkang Protective Products Co 9/15/16

BroadMaster Biotech Corp. 10/4/16

Zhejiang Bangli Medical Products Co., Ltd 1/26/17

Ausmetics Daily Chemicals (Guangzhou) Co., Ltd 1/31/17

Sato Pharmaceutical Co., Ltd. 2/2/17

Resonance Laboratories Private Limited 2/3/17


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