FDA 483 - Caraco Pharmaceutical Laboratories, Ltd. - May 30, 2013

During an inspection conducted from May 21 to May 30, 2013, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Caraco Pharmaceutical Laboratories, Ltd. The inspection revealed a significant observation concerning the company's container closure systems. Specifically, it was noted that the packaging for several lots of Carvedilol Tablets, USP, including 3.125 mg, 6.25 mg, and 12.5 mg strengths, did not comply with the United States Pharmacopeia (USP) specification for a "tight" container. The firm's labels explicitly state the requirement for a tight, light-resistant container and protection from moisture. However, the distributed container closure systems did not meet this standard, and Caraco Pharmaceutical Laboratories failed to provide sufficient data to demonstrate adequate protection of the drug product from external factors like moisture. This observation highlights a potential deficiency in ensuring drug product quality and integrity as per regulatory expectations. The company is required to review these observations and implement appropriate corrective actions to address the identified issues and ensure compliance with good manufacturing practices and product specifications.