The Food and Drug Administration has told Grato Inc. that it found significant violations of current good manufacturing practice (cGMP) regulations at the company’s pharmaceutical manufacturing facilities in Woodbine, Iowa, according to a warning letter posted Aug. 14 on FDA’s website.
FDA said it found the violations during an inspection that ended March 25, 2011.
The agency also said this inspection revealed that the personal care products company is manufacturing or marketing unapproved new drugs, or both.
Manufacturing Violations.
The violations observed include, but are not limited to, the following:
- the company has failed to investigate other batches of the ...
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