FDA WARNING_LETTER - Westbrook's Cannery, LLC. - July 24, 2015

The FDA inspected Westbrook's Cannery, Inc. from June 24 to July 24, 2015, and found serious violations of Acidified Food regulations (21 CFR Parts 108 and 114). These violations render their acidified food products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: * **Failure to follow scheduled process (21 CFR 114.80(a)(1) and 108.25(c)(3)):** Several lots of dilly beans were processed for shorter durations than the required minimum heating time of (b)(4). Process times for four lots of dill pickles could not be determined. * **Lack of temperature monitoring/recording:** Initial temperatures were not monitored or recorded for acidified pickles from June 12, 2014, to April 14, 2015, and never for acidified green beans from November 25, 2014, to June 22, 2015. * **Inadequate solids procedure:** The firm's procedure for ensuring maximum percent solids (weighing filled jars) was not adequately explained to ensure the critical limit of (b)(4) solids is not exceeded. * **Failure to maintain deviation log (21 CFR 114