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We’re not enforcing NDI draft guidance; GMPs are the biggest issue
date:May 11, 2012
mpanies, he said.


Dr Fabricant told attendees at the AHPA Botanical Congress that the most common areas of cGMP noncompliance discovered during FDA investigations, include:

Failure to prepare a master manufacturing record
Failure to prepare a batch record
Failure to establish specifications
Failure to determine if specifications are met
Failure of adequate quality control

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