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FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
FDA sent a warning letter to Pharmaceutic Labs, LLC, dated May 3, 2017 citing the company for violations of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA personnel inspected the company’s Albany, NY facility from Aug. 31, 2015–Sept. 23, 2015 and found inadequate sterile processing procedures and that the company was not meeting FDCA and Public Health Service Act (PHS Act) requirements for drugs produced by an outsourcing facility.
According to the warning letter, the company was producing biologic products without a biologics license and not under GMPs. FDA inspectors found that the company had not properly disinfecting aseptic processing areas. “Your firm failed to demonstrate through appropriate studies that your aseptic processing areas are able to provide adequate protection of the ISO 5 areas in which sterile products are processed. Therefore, your products may be produced in an environment that poses a significant contamination risk,” FDA stated in the letter. Other violations included failure to establish written procedures for the prevention of microbiological contamination, failure to establish an adequate cleaning and disinfecting system, failure to determine conformance specifications, and failure to establish laboratory controls.
FDA recommended that the company assess its facility design, procedures, personnel, processes, materials, and systems. “You should fully implement necessary corrections in order to ensure that the drug products produced by your firm conform to the basic quality standards regarding safety, identity, strength, quality, and purity,” FDA stated.