FDA WARNING_LETTER - Sabila SRL - December 20, 2012

The FDA inspected Sabila SRL's acidified food facility in the Dominican Republic on December 19-20, 2012, identifying serious deviations from 21 CFR Part 114 (Acidified Foods) and 21 CFR Part 110 (Good Manufacturing Practices). Despite receiving responses on January 9 and April 26, 2013, regarding intended changes and some addressed deviations (facility registration, wall/floor replacement), significant violations remained unverified.

Key violations include: * **Acidified Foods (21 CFR 108.25, 21 CFR 114):** Failure to file scheduled processes for Aloe Vera gel and (b)(4), lack of a supervisor trained in Better Processing Control School for acidified foods, and inadequate processing records (no thermal processing values, pH not checked before thermal processing). * **Good Manufacturing Practices (21 CFR 110):** Ineffective pest exclusion (over 100 flying insects, crawling insects, gaps in facility), improper plumbing (faucets in pooled water without backflow protection), non-cleanable utensils, uncalibrated instruments (thermocouples, scales), inadequate water quality (no measurable residual chlorine in wash water), uninspected and dirty raw material containers, and insufficient handwashing facilities (no hand sanitizers, no warm water, no signs, improper location).

These violations render products adulter