A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Alliance Medical Products, a contract manufacturer of commercial and clinical drugs, failed to follow environmental monitoring plans in classified areas and storage rooms, an FDA Form 483 states. Certain data regarding the setting of temperature and pressure limits is not reviewed by management per company protocol, FDA investigators said following a mid-April inspection. Drug GMP Report