FDA Inspection 680644 — New Spirit Naturals Inc.
The FDA completed an inspection of New Spirit Naturals Inc. on September 7, 2010 in San Dimas, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Dimas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |