Regulatory Focus™ > News Articles > FDA Warns Chinese Manufacturer for GMP, Training Issues

FDA Warns Chinese Manufacturer for GMP, Training Issues

Posted 15 August 2017 | By Michael Mezher 

FDA Warns Chinese Manufacturer for GMP, Training Issues

The US Food and Drug Administration (FDA) has warned Chinese manufacturer Foshan Flying Medical Products for testing and validation issues at its Guangdong, China facility.

According to Foshan's website, the company manufactures a range of medical products including first aid kits, bandages and over-the-counter (OTC) antiseptics.

The warning letter, dated 1 August, follows FDA's four day inspection of Foshan's site last February. The agency also placed the company on import alert in May as a result of the deviations observed during the inspection.

Warning Letter

In the warning letter, FDA says the company is not in compliance with current good manufacturing practices (cGMPs) and does not have a functioning quality control unit.

Specifically, the agency says Foshan's quality unit consisted of one employee that also worked in the production department, and that the quality unit lacked records demonstrating the acceptability of batches of drugs, such as change control documents, annual product reviews and batch record reviews.

FDA also says the company released finished drugs without adequately conducting acceptance testing or testing for critical microbial attributes and did not perform sterility testing for one of its products marketed as sterile.

And FDA says the company failed to retain batch records for its products for the requisite length of time.

"During the inspection, our investigator asked to review batch records f or your products. Your employee was only able to provide a single batch record for [redacted] your [redacted] products. When our investigator asked to see your other batch records, your staff stated that there were no other records. Your firm's senior management stated that batch records are only retained for approximately six months after production," FDA writes.

On top of those issues, FDA says that some of Foshan's employees were not trained and that the company's senior management confirmed it had not provided any cGMP-related training. Going forward, FDA says the company must come up with a training program for all employees who conduct or oversee manufacturing and keep records that demonstrate that employees are adequately trained.

In addition, FDA recommends that the company hire a qualified consultant to help it meet cGMP requirements.


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