FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.
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
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.