FDA Inspection 1013042 — Modern Herb Shop, Inc.
The FDA completed an inspection of Modern Herb Shop, Inc. on May 15, 2017 in Placerville, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Placerville, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |