FDA Inspection 1093190 — Novis PR, LLC dba Kramer Novis
The FDA completed an inspection of Novis PR, LLC dba Kramer Novis on June 13, 2019 in San Juan, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15803 | 21 CFR 111.560(c) | Product complaint -investigate, findings, follow-up |
| 15908 | 21 CFR 111.90(b)(1) | Reprocessed, dietary supplement - no material review |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |