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Pharmedica USA, LLC was cited for manufacturing drug products, including sterile preparations, under insanitary conditions at its Phoenix, Arizona facility during a November 2022 inspection. The company failed to maintain ISO classified cleanroom areas required for sterile drug manufacturing and allowed the facility to fall into a state of disrepair, resulting in products that were adulterated and potentially contaminated with filth. The FDA identified significant Current Good Manufacturing Practice (CGMP) violations, including the company's failure to establish and follow written procedures to prevent microbiological contamination of drug products. The company had not responded to the FDA's Form 483 observations prior to issuance of this warning letter.