FDA 483 - Lux Therapeutics LLC - May 12, 2023

Lux Therapeutics LLC, a biological drug manufacturer in Brookhaven, GA, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for lacking written quality control procedures for product receipt, failing to adequately segregate quarantined and distributed products, and having insufficient written procedures for monitoring product storage during transportation. These observations indicate a need for improved controls over product quality and integrity.