Campolor, Inc. – FDA Warning Letter, Sep 21, 2018

The FDA inspected El Tuque Industrial Park, Ponce, PR, from September 18-21, 2018, finding serious violations of 21 CFR Part 114, acidified food regulations. This renders their products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Failure to manufacture in accordance with the scheduled process (21 CFR 114.80(a)(1))**: Products like “(b)(4)” and “(b)(4)” sauces were not hot-filled at the required minimum (b)(4)°F, held inverted for (b)(4) minutes, or maintained at the specified maximum equilibrium pH of (b)(4). Vacuum measurement as a container closure test was also not conducted. The firm's response, stating a process authority was hired, was inadequate as it didn't detail implemented practices for adequate thermal processing and acidification. 2. **Scheduled process not established by a qualified person (21 CFR 114.83)**: Changes in raw materials, formulation, and preserving agents that could affect equilibrium pH were made without evaluation by a processing authority or notifying FDA. The firm's response was inadequate, failing to address corrective actions for products manufactured pending process evaluation. 3. **Operators not supervised by a qualified person (21 CFR 114.1