FDA Inspection 976997 — Novis PR, LLC dba Kramer Novis
The FDA completed an inspection of Novis PR, LLC dba Kramer Novis on May 17, 2016 in San Juan, PR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 17, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |