FDA 483 - Carecam International, Inc. - October 23, 2025

During an FDA inspection conducted from October 20-23, 2025, at an undisclosed pharmaceutical manufacturing facility located in Parsippany, NJ, investigators identified significant deviations from established cleaning and maintenance procedures. The primary observation noted that the firm failed to adhere to its written Standard Operating Procedures (SOPs) for the cleaning and upkeep of equipment and facilities involved in drug product manufacturing, processing, packing, and holding. Specifically, on October 20, 2025, following the packaging of a drug product identified as "ic | Tablets," the packaging room was documented as "partially clean." However, investigators observed packaging materials and even tablets from the previous production batch remaining in the room and on the floor, respectively. These findings directly contradict the firm's own SOP CC-402-R13, which mandates the removal of all previous batch materials and sweeping of the floor during partial cleaning procedures. These observations are reported under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicating conditions that could lead to drug products being prepared, packed, or held under insanitary conditions, potentially rendering them contaminated or injurious to health. The firm is expected to promptly address these critical observations, demonstrating corrective actions to ensure compliance with good manufacturing practices and prevent recurrence.