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Regulatory Focus™ > News Articles > 2019 > 8 > FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents

FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents

Posted 20 August 2019 | By Zachary Brennan 

FDA Warns Chinese OTC Drug Manufacturer for Falsifying Documents

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research earlier this month sent a warning letter to China-based sunscreen and OTC drug manufacturer NingBo Huize Commodity Co. after the company’s general manager and quality manager admitted that multiple documents provided to FDA were falsified “for the purpose of this inspection.”

FDA placed the firm on import alert in June and said that the firm agreed to recall all drug products distributed to the US market within expiry.

“Falsified documents include cleaning validation reports, batch records for multiple drug products, and annual product reviews,” the warning letter says. “Furthermore, you also stated that you could not provide basic records to support the CGMP requirements for the manufacture of drugs, including, but not limited to, the following:
  • equipment qualification (21 CFR 211.63);
  • raw material qualification and active pharmaceutical ingredient testing (21 CFR 211.84);
  • finished product and raw material testing qualification (21 CFR 211.165);
  • drug product stability program (21 CFR 211.166);
  • batch records (21 CFR 211.188); and
  • process validation (21 CFR 211.100).”
In addition to finding that the firm’s quality systems are inadequate, FDA also found that two of the company’s sunscreens were misbranded.

Polymer Technology Systems

FDA also warned Indianapolis-based Polymer Technology Systems late last month, finding that certain in vitro diagnostic medical devices made by the company are adulterated for failing to conform with the current good manufacturing practice requirements for medical devices.

FDA noted how a complaint “describes a malfunction of your firm’s CadioChek Analyzer resulting in melted plastic tablecloth in a hospital resulting from overheating CadioChek Analyzer batteries. In an oxygen-enriched environment, the malfunction resulting in melted materials may potentiate the possibility of a fire resulting in a death or serious injury, if it were to recur.”  And although Polymer became aware of the event on 4 December 2018, it failed to submit a malfunction Medical Device Report corresponding to the complaint.

The company was also found to have failed to validate or verify design changes before their implementation.

NingBo Warning Letter

Polymer Warning Letter
 

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