FDA Inspection 1169940 — Be Well Natural Medicine
The FDA completed an inspection of Be Well Natural Medicine on May 20, 2022 in Mill Valley, CA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 20, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mill Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18943 | FDCA 501(a)(2)(A) | Personnel in aseptic processing, non-sterile gloves |
| 18959 | FDCA 501(a)(2)(A) | Location, ISO 5 classified area |
| 18971 | FDCA 501(a)(2)(A) | No sporicidal agents, cleanroom and ISO 5 area |
| 18973 | FDCA 501(a)(2)(A) | Disinfecting materials, aseptic processing area |