FDA Inspection 1245322 — PureWater Dynamics, Inc.
The FDA completed an inspection of PureWater Dynamics, Inc. on Jul 31, 2024 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12703 | 21 CFR 129.80(a) | Product water samples after processing |
| 1423 | 21 CFR 129.37(d) | Containers kept sanitary |
| 1761 | 21 CFR 129.80(a) | Records - equipment inspection |
| 1806 | 21 CFR 129.80(b)(1) | Mechanical washers - records |
| 1812 | 21 CFR 129.80(c) | Sample, test - cleaning, sanitizing solutions |
| 18145 | 21 CFR 117.35(c) | Pest control |
| 18397 | 21 CFR 117.4 | Qualifications of individuals |
| 19027 | 21 CFR 117.126(a)(1) | Food safety plan |
| 2271 | 21 CFR 129.80(e) | Package identification |
| 2272 | 21 CFR 129.80(e) | Records - product, volume, date, code, distribution |
| 2273 | 21 CFR 129.80(g)(1) | Representative samples - bottled water |
| 2274 | 21 CFR 129.80(g)(1) | Bacteriological test - bottled water |
| 2301 | 21 CFR 129.80(f) | Bacteriological swab, rinse count - containers, closures (S) |