FDA 483 - SpecGx LLC - January 22, 2019

Spec Gx LLC, an API manufacturer in Greenville, IL, was cited for failing to document a required inspection on batch records. Inspectors found that four out of six reviewed Compap Coarse L batch production records lacked documentation of a critical inspection, despite these lots being reviewed by quality and manufacturing and subsequently released for distribution. This indicates a breakdown in adherence to established quality control procedures and documentation practices.