FDA WARNING_LETTER - Hawks Nuts, Inc. - July 27, 2012

On November 20, 2012, the FDA issued a Warning Letter to Hawks Nuts, Inc., following an inspection from July 17-27, 2012, of their low-acid canned food facility in Tampa, Florida, which manufactures canned, ready-to-eat (RTE) boiled peanuts. The inspection revealed serious deviations from Low-Acid Canned Food regulations (21 CFR 108 and 113) and Good Manufacturing Practices (21 CFR 110), rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Processing Deviations:** Process timing began before proper retort venting and temperature was reached (21 CFR 113.40(a)(12)). The vent was observed partially open during the cycle, and no documented venting cycle information from a process authority was available. 2. **Temperature Control:** The temperature-recording device was purposefully adjusted to read higher than the mercury-in-glass thermometer, contrary to 21 CFR 113.40(a)(2). 3. **Initial Temperature Monitoring:** Failure to determine and record the initial temperature of container contents with sufficient frequency (21 CFR 113.87(c)). 4. **Drained Weight Monitoring