Aranda's Pickled Mushrooms, LLC – FDA Warning Letter, Jun 29, 2011

An FDA inspection of Aranda's Pickled Mushrooms, LLC, conducted on June 21, 23, and 28-29, 2011, revealed significant violations of federal regulations for acidified food products (21 CFR 108 and 21 CFR 114) and food labeling (21 CFR 101). The firm's "Aranda's brand Whole Pickled Mushrooms" were deemed adulterated under 21 U.S.C. § 342(a)(4) due to preparation under insanitary conditions and misbranded under 21 U.S.C. § 343 due to false/misleading statements and non-compliance with labeling regulations.

Key violations include: 1. Failure to manufacture in conformity with the filed scheduled process (21 CFR 108.25(c)(3)(i)), specifically not documenting processed time. 2. Failure to ensure finished equilibrium pH values are not higher than 4.6 by not conducting equilibrium pH testing on all finished batches (21 CFR 114.80(a)(2)). 3. Failure to maintain processing and production records showing adherence to scheduled processes, including time and temperature documentation (21 CFR 114.100(b)). 4. Failure to employ appropriate quality control procedures (21 CFR 1