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

Source: https://www.keypedia.com/records/eir/real-water-inc/b291c323-63e4-4a85-be45-776e9509eaa9

> 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: Office of Human and Animal Food Operations
- Summary: An FDA inspection conducted at Real Water, Inc. in Mesa, AZ, from March 22 to April 7, 2021, revealed significant compliance issues. This unannounced inspection was part of a critical assignment related to a potential outbreak investigation and covered Good Manufacturing Practices (GMP) and Preventive Controls for Human Food (PCHF), as well as bottled water regulations (21 CFR Part 117 and 21 CFR Part 129).

The inspection resulted in four key observations documented on an FDA-483 form. Firstly, the company's hazard analysis was deficient, failing to identify crucial chemical hazards from misformulation during the mixing and receiving (supply chain) steps, lacking written control procedures, validation, and supplier approval. Secondly, a critical lack of sanitation preventive controls was noted, with equipment not being cleaned or sanitized, inadequate employee hygiene practices, and no environmental monitoring to prevent pathogen recontamination. Thirdly, Real Water, Inc. failed to collect product water samples after processing and prior to bottling, and lacked records for such testing. Lastly, the company did not properly record essential production information, including product type, volume, date, lot codes, and distribution for its finished bottled alkaline water, nor did it perform required annual and weekly water sample analyses.

Management was informed of the findings and the potential for legal sanctions, including seizure and injunction, if corrective actions are not implemented. The company's Production Manager, Mr. Brown, acknowledged the observations, committed to implementing corrective actions within 90 days, and agreed to seek training to establish a Preventive Controls Qualified Individual.

## Related Documents

- [EIR - 2021-04-07](https://www.keypedia.com/records/eir/real-water-inc/1b4a2368-ce35-468f-a47a-f89058731f72)
- [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)
- [issuing_officer](https://www.keypedia.com/people/debra-devlieger/8430574d-22f4-4c7e-a52a-89f661ca20a4)
- [investigator](https://www.keypedia.com/people/erica-r-woody/8e16d38d-ad58-46e8-bc08-fbf67fb2d7a6)
- [James P. Stallings](https://www.keypedia.com/people/james-p-stallings/f7497423-39b9-4929-8d60-9463f07c2b7a)

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

Office: https://www.keypedia.com/offices/office-of-human-and-animal-food-operations/cf23dae6-1323-4680-9a7e-ac4ee8c3c287