FDA EIR - Albanese Confectionery Group, Inc. - May 05, 2017

An FDA inspection of Albanese Confectionery Group, Inc. in Merrillville, IN, was conducted from April 24 to May 5, 2017, focusing on their dietary supplement gummy manufacturing. The inspection, carried out under the regulatory framework of the Compliance Program Guidance Manual for Dietary Supplements (CPGM 7321.008) and the Food Drug & Cosmetic Act, identified significant deficiencies. This follows a previous dietary supplement inspection in March 2014 which also resulted in observations. The inspection concluded with the issuance of a 15-point FDA Form 483, highlighting critical violations in manufacturing practices. Main issues included the company's failure to adhere to its Master Manufacturing Records (MMRs) during production, with actual batch records not reflecting specified temperatures, mixing times, or ingredient quantities. Albanese Confectionery also failed to prepare unique MMRs for each batch size and did not include necessary specifications for quality control, packaging, and labeling steps within their MMRs. Crucially, the MMRs lacked written instructions for corrective actions when specifications were not met, accurate component weights, and procedures for verifying manual and automated component additions. Furthermore, Batch Production Records (BPRs) were incomplete, missing actual and theoretical yield statements, and dates for equipment cleaning. The company also did not maintain proper calibration documentation, stored components in a manner susceptible to contamination, lacked procedures for returned products, and failed to adequately qualify a supplier by confirming the reliability of their certificates of analysis. Some of these issues, such as performing identity tests and supplier qualification, were repeat observations from the 2014 inspection. Management's immediate required action is to submit a written response addressing each observation on the FDA Form 483, outlining their corrective measures to bring operations into compliance with regulatory standards.