FDA Inspection 1150123 — Pharmavite LLC dba Nature Made
The FDA completed an inspection of Pharmavite LLC dba Nature Made on August 27, 2021 in San Fernando, 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Fernando, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15494 | 21 CFR 111.25(c) | Procedures - equipment - cleaning, sanitizing |
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |