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Shertech’s Operations Halted by 483 Citing Procedural Lapses

Shertech Laboratories received a Form 483 after investigators found an array of procedural lapses that ultimately led the company to halt its first try at manufacturing prescription generics. The Form 483 followed an inspection of Shertech’s Duncan, S.C., facility in early November. Investigators with the FDA’s Atlanta District office made 25 observations, most of which centered on the startup’s failure to document quality control responsibilities and procedures.
Drug GMP Report