FDA PROVIDES NO RATIONALE FOR ALERT
After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly intrigued by the Blog because one had observed an Import Alert that was issued by the FDA on March 18, 2014, but could find no information to support it. Another individual indicated that the FDA may issue an Import Alert if there appears to exist through an inspection so many critical findings that immediate action is required.
A somewhat similar Blog in 2011 was written wherein H&P Industries had two rather significant FDA Form 483s in 2011, never was issued a Warning Letter, but rather had product seized several months later and then several months after that was issued a Consent Decree. When the FDA deems that significant harm may occur to the general population, they may take rapid action.
Another colleague purchases upstream compounds to use as starting materials. The question raised by this individual was “If API manufacturer(s) purchase materials from this company, could it cause problem?â€
For an answer to this question, I refer to ICH Q7. Within ICH Q7,
7.1 General Controls
7.10 There should be written procedures describing the receipt, identification, quarantine, storage, handling, sampling, testing and approval or rejection of materials
7.11 Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials
7.13 If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer should be known by the intermediate and/or API manufacturer
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