FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Inadequate Controls, Faulty Test Methods Lead to Form 483 for Softech Pharma

Feb. 8, 2017

The FDA came down on Softech Pharma, handing them a Form 483 after an inspection of their India facility revealed 12 issues.

The majority of the deficiencies dealt with faulty records.

Investigators also found that raw materials used in the production of drug products were used prior to adequate testing.

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