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Posted 19 September 2012 | By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) regularly inspects thousands of manufacturing facilities around the globe. What isn't so regular is the owners of one of those facilities throwing FDA inspectors in the middle of an inspection and in the midst of allegations of serious manufacturing problems.
According to FDA, the agency had arranged to inspect Fercy Personal Care Products' Jinhua, China-based manufacturing facility between 5 March and 9 March. The inspection started as planned, but was abruptly terminated on 6 March when, according to FDA, it started to raise concerns about manufacturing and documentation practices at the facility.
"Your decision to terminate the inspection prevented the FDA Investigator from reviewing relevant records related to the production, testing and holding of drug products intended for the US market, not being readily available for inspection," FDA wrote in its 7 September warning letter. "These unreasonable delays or denials in permitting FDA to access manufacturing conditions at your facility give the appearance that your products do not meet U.S. regulations and standards."
FDA added that the company had previously requested canceling the inspection altogether, further raising the agency's concerns regarding the quality of the products produced there.
FDA has since put the firm on an import alert, barring its products from entering the country, and its warning letter demands documentation for all drug products distributed to the US. In addition, FDA said it requires Fercy to send FDA the company's, "Rationale for your premature termination of the inspection."
The remainder of FDA's warning letter alleges the agency's inspectors found a number of other troubling things, including poor documentation procedures. "The only documentation available on site for the batches of drug products manufactured by your firm was two pages from a notebook listing the ingredients used," FDA wrote.
FDA also said it found no written control procedures for ensuring batch consistency or quality, no record of batch release testing and no record of batch stability testing to assess the date of expiry. Further, FDA said the company had failed to register its facility with the agency, instead maintaining an alternate address on file.
"In addition to the items listed above, the investigator found many other deficiencies that lead us to question the effectiveness of your current quality system to achieve overall compliance with current Good Manufacturing Practices (CGMPs) at your facility," the agency said, and recommended the company seek the assistance of third-party regulatory consultants to bring the facility into a state of compliance.
Tags: Inspectors, Warning Letter Analysis, warning letter, Latest News, cGMP
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