FDA Inspection 683292 — H2O Plus, LLC
The FDA completed an inspection of H2O Plus, LLC on Sep 30, 2010 in Chicago, IL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |