FDA WARNING_LETTER - Bella Cucina Artful Food, Inc. - February 21, 2008

An FDA inspection conducted from February 12-21, 2008, at 1870 Murphy Avenue, SW, Atlanta, Georgia, revealed significant deviations in the manufacturing of various acidified food products. The facility failed to comply with the Federal Food, Drug, and Cosmetic Act, specifically 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods). These failures render the firm's acidified food products adulterated under Section 402(a)(4) of the Act, indicating preparation, packing, or holding under insanitary conditions. Key violations include: 1) Failure to file scheduled processes for each acidified food and container size, a recurring issue from a 2006 inspection. 2) Failure to ensure finished equilibrium pH values of 4.6 or lower for products like Porcini and Parmesan Pesto, with FDA analysis showing pH values up to 4.98. 3) Failure to maintain adequate processing and production records, specifically lacking documentation of critical factors like the 160°F center container temperature for 1 minute. 4) Failure to have personnel involved in critical operations (acidification, pH control, heat treatment) supervised by an individual who completed an approved Better Process Control school. 5) Failure to adequately maintain and calibrate instruments, such as thermometers, used for monitoring critical conditions. Additionally, the firm was noted for pre-recording process end times and for not evaluating Spinach and Artichoke Pesto to determine if it is an acidified food. The FDA requires prompt corrective action, including a written response within fifteen working days detailing specific steps taken, recurrence prevention, responsible personnel, and supporting documentation. Failure to comply may result in regulatory actions such as seizure or the issuance of a Temporary Emergency Permit.