Deviations from current good manufacturing practices (cGMP) were discovered in December 2007 at G&W’s New Jersey plant by FDA inspectors, according to the agency.
G&W issued several responses at the start of the year after the FDA raised several concerns from the plant inspection. However the agency’s warning letter maintains that GMPs were not being adhered to in some aspects of the manufacturing process.
Several of the FDA’s issues centre upon the production of Formulation R Hemorrhoidal Ointment. The agency claims G&W scaled the batch size of Formulation R without performing a study.
The FDA believes “this lack of attention to process design appears to have been a factor in inadequate mixing of at least one batch of Formulation R product”.
“Inadequate mixing” is a reference to samples taken by agency inspectors that it is claimed revealed concentrations at the bottom of a holding tank that exceeded the in-process acceptance criteria. This batch was not rejected by the company, according to the FDA.
Agency inspectors also reported on poorly maintained equipment, including tape flaking off filling equipment directly above an uncovered hopper, two leaks in the purified water system and a leaking gasket in the product transfer line.
The FDA’s warning letter said G&W’s efforts to remedy these faults was “adequate”but expressed concern about the plant’s “multiple conditions of disrepair” that were noted by inspectors.
Further alleged deviations from GMP centred on what the FDA believes were “incomplete investigations” into the presence of black particles in a batch of Formulation R that was rejected.
G&W has stated that a pump was replaced during the manufacture of the batch. However, the agency has said there is no record of this maintenance and that G&W should have analysed the black particles and investigated other batches.
The company maintains that the source of the black particles was evident from its investigations. In the warning letter the FDA also accuses the company of performing an incomplete investigation into the presence of Escherichia coli in purified water samples.
G&W must issue a response within 15 days of receiving the letter detailing the steps it has taken to resolve the issues. The response was not published on the FDA’s website at the time of publication.
The company declined to comment when contacted by in-PharmaTechnologist.com.