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FDAnews Drug Daily Bulletin
Apotheca Cited for cGMP Violations in FDA Warning
Sept. 10, 2012
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.
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