Regulatory Focus™ > News Articles > 2019 > 1 > FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

Posted 29 January 2019 | By Michael Mezher 

FDA Warns Chinese OTC Drugmaker, Florida Fertility Center

The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.
 
Hangzhou Guoguang
 
The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.
 
According to the warning letter, Hangzhou Guoguang violated GMP requirements by manufacturing drugs on shared equipment without validated cleaning procedures, having an inadequate quality control unit and failing to adhere to product testing requirements.
 
FDA says the company made several over-the-counter (OTC) drugs "on shared equipment you use to manufacture non-drug products," including one unnamed product that would make the use of shared equipment for drug manufacturing "unacceptable".
 
As such, FDA is ordering the company to discontinue manufacturing drug products on shared equipment with non-drugs until it has validated its cleaning procedures for non-dedicated equipment and ensure that the aforementioned unnamed product is made in a separate area of the facility from any drug products.
 
FDA also says that Hangzhou Guoguang's quality control unit failed to ensure that products were not released before analytical testing was completed and reviewed, and in some cases released products that were out-of-specification (OOS).
 
The agency cites two instances in which batches of drugs were distributed before the quality control unit reviewed or received assay results for those batches.
 
In response, FDA says the company must conduct a root cause assessment of its quality control unit's failures and perform a review of "all lots of OTC drug products within expiry that were distributed in the United States" to determine whether any of those lots also failed to meet specifications.
 
FDA also took issue with Hangzhou Guoguang's testing procedures. According to the agency, the company distributed products "without testing the identity, strength, purity, and quality of the active ingredient."
 
Additionally, FDA says the company did not adequately test its products to ensure stability within their labeled expiration dates.
 
"For example, your stability testing program does not include an assay determination of the active ingredient(s) in your OTC drug products," FDA writes.
 
Due to these issues, FDA is recommending that the company hire a GMP consultant to assist it in bringing its operations up to par.
 
University of Miami Reproductive and Fertility Center
 
FDA's Center for Biologics Research and Evaluation (CBER) warned the University of Miami Reproductive and Fertility Center early last month for failing to adhere to donor screening requirements for Zika virus (ZIKV).
 
The inspection, which occurred last July, found that the fertility center did not adequately screen for ZIKV and improperly determined donors to be eligible despite the risk.
 
"From July 29, 2016 to June 2, 2017, Miami-Dade County in Florida was listed as an area at increased risk for Zika virus (ZIKV) transmission … therefore, [human cells, tissues, and cellular and tissue-based products] HCT/Ps donors who traveled to your establishment during this time period were at increased risk for ZIKV transmission and should have been determined ineligible due to ZIKV risk," FDA writes.
 
The warning letter cites three situations where donors were determined eligible despite not being screened for ZIKV.
 
FDA also says the fertility center failed to include questions on its self-administered donor screening form to assess the risk for ZIKV and syphilis. The questionnaire also improperly states that donors who tested positive for West Nile Virus should defer for 28 days from the onset of symptoms, despite FDA's recommendation that donors who have a diagnosis or suspicion of West Nile Virus defer for 120 days.
 
Hangzhou Guoguang, University of Miami Reproductive and Fertility Center

 

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