FDA Inspection 1255907 — Ethical Nutritional, LLC
The FDA completed an inspection of Ethical Nutritional, LLC on Dec 5, 2024 in Pomona, 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 5, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |