Warning Letter to Fercy Personal Care Products - company kicked out FDA

AnaMariaVR2

Trusted Information Resource
Fercy Personal Care Products Co. terminated US FDA inspection before its conclusion...:mg:
Warning Letter > WL: 320-12-023

http: // www .fda. gov/ICECI/EnforcementActions/WarningLetters/2012/ucm319504.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED


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.”

Other Alleged Deficiencies
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.

Fercy website:
https://www.fercy.com/index.asp
 
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Wes Bucey

Prophet of Profit
What this points up, in my opinion, is that customers (American Corporations) are contracting with offshore companies to import either products or components of products without performing ANY due diligence in the quality of the product or the processes used to produce them.

I'm curious if this FDA target has any registration to an International Quality Management Standard which might have lulled the American buyers into a false sense of security.

I have a suspicion this may be a case of "low price puts blinders on purchasing. '
 

AnaMariaVR2

Trusted Information Resource
I read their company profile & there is no mention of QMS registration. I'm attaching the screenshot of it as of today before they take it down or change it (for example & discussion purposes only).

Another aspect which I find interesting is the extent of the repercussions of American buyers trying to save a buck here & there while disregarding quality...& how the lack of quality can be very insidious.

How is that the reputation of a Chinese personal care product's company affect an American furniture company? Look at the "hook in lip balm" product sample on their site...

I wonder if Ashley Furniture is aware that promotional material (lip balm) distributed to their customers or potential customers came from Fercy.

WOW...
 

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Wes Bucey

Prophet of Profit
I looked (for about 15 minutes) at furniture in the local Ashley Furniture in the next town - I wasn't too impressed with the quality of the furniture on display, so I suppose there's no mystery about the lack of concern about quality of promotional items, either.
 
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