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Regulatory Focus™ > News Articles > 2019 > 2 > FDA Warns Chinese OTC Drugmaker, Releases 3 Form 483s

FDA Warns Chinese OTC Drugmaker, Releases 3 Form 483s

Posted 20 February 2019 | By Zachary Brennan 

FDA Warns Chinese OTC Drugmaker, Releases 3 Form 483s

The US Food and Drug Administration (FDA) on Wednesday released a warning letter sent to China-based Hangzhou Sunking Nonwovens Co. citing significant violations of current good manufacturing practice regulations for finished pharmaceuticals.

The warning letter, which noted the firm was placed on import alert last December, highlighted how over-the-counter (OTC) drug products were released for distribution in the US without appropriate quality control release testing.

In addition, FDA raised concerns about the validity of test results for Hangzhou Sunking Nonwovens’ finished drug product.

“Your firm lacked testing of incoming raw materials, used in the manufacturing of your drug product, including active pharmaceutical ingredients and other components, for their identity, strength, and other quality attributes. Your firm also relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of the suppliers’ analyses through appropriate validation,” FDA said.

The firm also did not have stability data to support the expiration dates assigned to its OTC drug product.

“Without stability data, you cannot assure the quality of your drug products throughout their labeled shelf lives,” FDA added.

And the firm was found to lack an adequate quality unit, without written procedures for numerous functions.

Form 483s

In addition to the warning letter, FDA on Tuesday released three Form 483s sent to lmmunomedics, Lupin and Dr. Reddy’s. The Lupin and Dr. Reddy's 483s were issued earlier in February to the companies while the one for Immunomedics was from last August.

The 483 for New Jersey-based Immunomedics, following an inspection last August, notes that the firm’s quality control unit lacks the appropriate authority to investigate critical deviations of approved procedures.

“Specifically, the discovery of a data integrity breach in February 2018 did not trigger a deviation,” FDA said.

The 483 issued to Lupin, meanwhile, followed an inspection late last month and earlier this month and features two observations, including one that deals with the failure of a batch or any of its components to meet certain specifications, whether or not the batch has already been distributed. The Lupin site has previously received an FDA warning letter.

And the Dr. Reddy’s 483, also sent to the firm following an inspection from earlier this month and last month, includes 11 observations. The heavily redacted 483, for a site located on the outskirts of Hyderabad, notes that in some instances, investigations initiated in response to complaints are not always adequate.

FDA also found the Dr. Reddy's site’s quality control unit lacks the authority to review production records to ensure no errors have occurred and to investigate the errors that have occurred.

In November 2015, FDA sent a warning letter to three Dr. Reddy's Laboratories sites also located just outside of Hyderabad.

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