FDA Inspection 666020 — Vita-Herb Nutriceuticals Inc
The FDA completed an inspection of Vita-Herb Nutriceuticals Inc on June 29, 2010 in Placentia, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 29, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Placentia, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15468 | 21 CFR 111.20(c)(2) | Physical plant - material review and disposition |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |