# FDA EIR - Real Water, Inc. - April 07, 2021

Source: https://www.keypedia.com/records/eir/real-water-inc/1b4a2368-ce35-468f-a47a-f89058731f72

> FDA EIR for Real Water, Inc. on April 07, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Real Water, Inc.
- Inspection Date: 2021-04-07
- Product Type: Food
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Real Water, Inc.'s Mesa, AZ facility, conducted from March 22 to April 7, 2021, uncovered critical violations regarding food safety and bottled water regulations. This unannounced inspection, part of a coordinated outbreak response and focusing on Preventive Controls for Human Food (PCHF) and Good Manufacturing Practices (GMP), highlighted significant deficiencies. The firm failed to identify and implement preventive controls for chemical hazards related to product misformulation during mixing and receiving E2 concentrate, an ingredient with an unknown formulation. Additionally, environmental pathogen recontamination was not identified as a hazard requiring sanitation preventive controls, with critical issues like uncleaned equipment (e.g., mix tank since September 2020) and inadequate employee hand hygiene noted. Other violations included not taking product water samples after processing and prior to bottling, a lack of comprehensive record-keeping for production and distribution information, and the absence of required annual and weekly testing for bottled drinking water. A key finding was the firm's lack of a Preventive Controls Qualified Individual (PCQI). Regulatory frameworks cited include 21 CFR 117 and 21 CFR 129. While management verbally committed to correcting these observations within 90 days, including establishing proper controls, sampling, record-keeping, and pursuing PCQI training, the inspection report noted the status as "Not Corrected" at its conclusion. Legal sanctions were outlined to management should corrective actions not be adequately taken.

## Related Documents

- [EIR - 2021-04-07](https://www.keypedia.com/records/eir/real-water-inc/b291c323-63e4-4a85-be45-776e9509eaa9)
- [483 - 2021-04-07](https://www.keypedia.com/records/483/real-water-inc/571e7ab7-ce0d-4521-8e53-cb9cd5452efe)

## Related Officers

- [investigator](https://www.keypedia.com/people/manuel-a-moreno/1dee7872-ea2c-4c2e-a1e1-16b05d1842fa)
- [investigator](https://www.keypedia.com/people/erica-r-woody/8e16d38d-ad58-46e8-bc08-fbf67fb2d7a6)
- [issuing_officer](https://www.keypedia.com/people/debra-devlieger/8430574d-22f4-4c7e-a52a-89f661ca20a4)
- [James Stallings](https://www.keypedia.com/people/james-stallings/b0ba7de3-63be-44c3-92cf-94f8544302d4)

Company: https://www.keypedia.com/companies/real-water-inc/a00aeb77-ee38-4bcb-986d-f1214b8f8dd2

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b