# FDA WARNING_LETTER - Campolor, Inc. - September 21, 2018

Source: https://www.keypedia.com/records/warning_letter/campolor-inc/fa53dd89-5122-4edb-a33e-cd76d49539aa

> FDA WARNING_LETTER for Campolor, Inc. on September 21, 2018. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Campolor, Inc.
- Inspection Date: 2018-09-21
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

## Related Officers

- [Program Director](https://www.keypedia.com/people/ramon-a-hernandez/12807db4-f78b-4579-b66c-bae9096ec2d4)

Company: https://www.keypedia.com/companies/campolor-inc/b260b06e-2495-4949-afa6-21b16453ec4c

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2