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Apotheca Cited for cGMP Violations in FDA Warning

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FDA inspections of Apotheca have revealed possible metal shaving contamination and broken, leaking or damaged bottles for various drugs, resulting in a warning letter. The letter criticized Apotheca’s lack of a scientific justification for releasing potentially contaminated drugs. Further, Apotheca decided that investigations into 19 complaints associated with the bottle issues were unnecessary.
Drug GMP Report