Institute of Good Manufacturing Practices India®

FDA issues warning letter to Coupler Enterprises for GMP deficiencies in packaging


US-FDA recently issued a Warning Letter to Coupler Enterprises, a pharmaceutical manufacturer, for GMP deficiencies in its packaging and quality assurance. The warning is related to the manufacturer's procedure for line clearance, equipment cleaning, and investigation of deviations.

USFDA conducted an inspection of the manufacturing facility of Coupler Enterprises in February and March, where various inadequacies were observed. In the absence of SOPs, the FDA noted improper line clearance and inadequate cleaning of the production area and equipment. 

The SOPs were deficient in the company's Quality Unit as well. Thus, the standard deviation investigation seemed to be improper. FDA observed around 11 cases of inadequately investigated deviations. 

The warning letter also mentions that none of the production equipment was approved for quality by the company's quality unit.