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Libby Laboratories, Inc. manufactured OTC sunscreen and hospital-use antiseptic drug products in violation of Current Good Manufacturing Practice (CGMP) regulations. During a March 2025 inspection, investigators found that the company failed to conduct required microbiological testing on finished product batches prior to release, including a batch of antiseptic distributed to a children's hospital in September 2024, leaving no scientific evidence that products were free of objectionable microbial contamination. The company's April 2025 response claiming that certain antimicrobial ingredients made additional testing unnecessary was insufficient to address the mandatory testing requirement under 21 CFR 211.165(b).