BMF, Inc. – FDA Warning Letter, Apr 17, 2019

On September 18, 2019, the FDA issued a Warning Letter to a bottled water manufacturing facility in Caguas, PR, following an inspection from March 29 to April 17, 2019. The inspection revealed serious violations of 21 CFR Part 129 (Processing and Bottling of Bottled Drinking Water Regulations) and 21 CFR 101 (labeling), rendering products adulterated and misbranded.

Key violations include: 1. **Failure to conduct follow-up testing for *Escherichia coli*** after coliforms were detected in source water (Well (b)(4)) on March 25 and March 8, 2019, as required by 21 CFR 129.35(a)(3)(i). The firm also failed to collect and analyze weekly total coliform samples from the well between February 11 and March 22, 2019. The firm's response was inadequate as it did not address the root cause or preventive actions. 2. **Failure to analyze representative samples of bottled drinking water for (b)(4) testing** at least (b)(4) a week for each type of bottled water, as required by 21 CFR 129.80(g)(1). This was observed for products from (b)(4) and (b)(4