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The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
FDA sent a warning letter, dated April 28, 2023, to Pharmedica USA, after an inspection of the company’s Phoenix facility found drug products meant to be sterile being prepared, packed, or held under insanitary conditions. The company also lacked International Organization for Standardization (ISO) classified areas for sterile drug manufacturing.
In addition, a variety of current good manufacturing practice violations were found, including failure to establish and follow written procedures to prevent microbiological contamination. “During the inspection, you informed us that you were unaware that ophthalmic drug products are required to be sterile and acknowledged that your facility is not designed and equipped to handle or manufacture sterile drug products, even though your drug products are intended for use as ‘eye drops,’” the agency stated in the letter.
The company also failed to establish adequate procedures for production and process control. “You failed to adequately qualify the equipment and validate the processes used to manufacture your drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an ongoing program for monitoring process control, to ensure stable manufacturing operations and consistent drug quality for products in US distribution,” the agency stated.
These and other quality control problems led to a product recall and a cease of production at the Phoenix facility.