Pennsylvania Facility Receives Warning Letter

FDA sent a warning letter, dated Sept. 13, 2019, to Dercher Enterprises, Inc., DBA Gordon Laboratories, after an inspection of Gordon Laboratories’ facility in Upper Darby, PA, found violations of current good manufacturing practices (CGMPs) and that the company was manufacturing adulterated drug products. The inspection was conducted from March 7–29, 2019.

According to FDA, the company failed to properly investigate unexplained discrepancies or batch failures. The agency requested the company provide interim plans for manufacturing and distributing product during remediation of “the sources of variability that have led to recurring assay failures”; an investigation and corrective action and preventive action (CAPA) plan for identifying manufacturing root causes; a procedure for investigating out-of-specification results; and an independent assessment of the company’s overall investigation system.

The letter also states that the company did not conduct appropriate laboratory testing for each batch of drug product. “Drugs that may be applied to non-intact skin must be free of objectionable microorganisms and, where appropriate, should be sterile. However, you failed to establish specifications for microbiological quality. Moreover, you failed to test your finished drug products for microbial quality (total microbial counts and objectionable microorganisms) prior to release and distribution,” FDA stated in the letter.

The agency requested the company provide appropriate microbiological batch release specifications for each drug product; microbiological test methods for analyzing drug products; an assessment of microbiological controls and contamination prevention; a summary of test results obtained from testing reserve samples; and a complete investigation into all lots found to have objectionable microbial contamination.

The company also failed to establish an adequate quality control unit, according to FDA, and failed to establish and follow adequate written procedures. “Without an adequate Quality Unit (QU), you are unable to ensure that drug products meet required specifications and manufacturing standards for safety, identity, strength, quality, and purity. You are responsible for establishing the reliability of your suppliers’ test results and conformance to all written specifications,” the letter stated.

Source: FDA