FDA WARNING_LETTER - Oregon Wild Berries, Inc. - May 23, 2017

The FDA conducted an inspection of your low-acid canned food processing facility in Westport, Oregon, from May 9 to May 23, 2017, identifying serious violations of the low-acid canned food regulations (21 CFR 113). The facility manufactures products like clam chowder, oyster stew, and various soups. Key deficiencies included the failure to provide heat distribution data for retort venting (21 CFR 113.40(a)(12)), inadequate measurement and recording of critical factors in scheduled processes (21 CFR 113.40(a)(13)), failure to identify deviations from the filed scheduled process (21 CFR 113.89), and insufficient recording of visual container closure examinations (21 CFR 113.60(a)). The firm's June 1, 2017, response to the FDA 483 was deemed largely inadequate, lacking narrative descriptions of corrective actions and failing to fully address the observations. The FDA requires prompt corrective action within fifteen business days, including documentation and a timetable for completion, to prevent further regulatory actions such as seizure, injunction, or the requirement for a Temporary Emergency Permit, and potential reinspection fees.