FDA Letters Slam Four Compounders Over Sterility, Prescription Issues

July 22, 2016

Four compounders recently received FDA warning letters that faulted them over sterility concerns and other issues.

FDA inspectors noted that Complete Pharmacy and Medical Solutions failed to use effective sporicidal agents as part of its disinfection programs for the clean room and ISO 5 area. During an August 2014 inspection, investigators noted that the Miami Lakes, Fla.-based company did not have adequate procedures to sterilize and depyrogenate glass vials and rubber stoppers.

The company also failed to demonstrate that its laminar flow hoods provided adequate protection of the ISO 5 area where sterile products are manufactured.

FDA investigators identified a slew of GMP violations as well. For example, the compounder failed to establish and follow written procedures to prevent microbiological contamination, which includes validating all aseptic and sterilization processes.

According to the warning letter, the company did not implement appropriate lab controls for determining final specifications. Additionally, the agency said the company lacked sufficient controls for preparing and applying labels to ensure conformity to batch production records.

The warning letter states that the compounder neglected to include a list of inactive ingredients —identified by name and quantity — on the labels or containers of drug products and excludes information on reporting adverse events to the agency.

The agency is asking the company to provide a scientific justification for its new depyrogenation procedure, implement active air monitoring and supply documentation for its revised procedures for inspecting finished products.

An August 2015 inspection of Bedford Pharmacy found the company did not use a sporicidal agent or sterile wipes in its disinfection program for its aseptic processing area.

FDA inspectors noted that the Bedford, N.Y.-based company had equipment where aseptic processing occurred, but it was located in an unclassified room and was turned off when not in use. The firm provided a statement from the manufacturer saying that the current location was appropriate, but the letter notes that the location of the equipment does not mitigate the risk of microbial contamination from the influx of unfiltered air during routine cleaning and maintenance.

The facility also failed to demonstrate through appropriate studies that its aseptic processing area adequately protects the ISO 5 area.

The agency is requesting the company address microbial contamination concerns related to the location of the equipment, provide sufficient evidence that proposed cleaning and disinfecting procedures yield appropriate aseptic processing conditions and a detailed description of the conditions during smoke studies or a video of the studies.

Another compounder that wound up in the agency’s crosshairs is PharmaLogic Holdings.

The pharmacy was cited over its handling and preparation standards, with the letter arguing that clean rooms at an outsourcing facility in Boca Raton, Fla., were unsanitary.

The facility also was hit with several GMP citations, including failure to establish an adequate system for cleaning and disinfecting rooms and equipment, neglecting to set proper written procedures to prevent microbiological contamination of drug products and failing to withhold lots before testing and sampling.

The final compounding letter — and the shortest of the bunch — went to Madison Drugs over the company’s compounding without prescriptions. The agency also contends that the company’s facility in Huntsville, Ala., misbranded its products because they lack sufficient directions for a layman to understand.

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