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FDA Slaps Drug Manufacturer With Six-Item Form 483

May 13, 2016

The FDA is accusing a New York-based drug manufacturer of multiple GMP violations, including laboratory control issues.

Chief among the inspectors’ complaints was that laboratory controls at Topiderm’s facility in Amityville, N.Y., were not deemed to be scientifically sound. The inspector noted that the company does not use method blanks in at least one testing procedure.

Additionally, the investigators observed deviances from test procedures during the incubator validation and verification, although the particulars of this issue could not be determined due to multiple redactions.

 

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