FDA Inspection 1196582 — NOVOGENIA GMBH
The FDA completed an inspection of NOVOGENIA GMBH on Jan 30, 2023 in Eugendorf. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 30, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Eugendorf (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15677 | 21 CFR 111.315(b)(1) | Sampling plans; components |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |