FDA Inspection
Novis PR, LLC dba Kramer NovisFDA Inspection 1093190 - Novis PR, LLC dba Kramer Novis - June 13, 2019
Record Details
This FDA Inspection record concerns Novis PR, LLC dba Kramer Novis, with an inspection on June 13, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- June 13, 2019
- Product Type
- Food/cosmetics
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ID · efb3aed1-77ef-43d4-b30c-8f5e52151c87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093190
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
3- 21 CFR 111.90(b)(1)Reprocessed, dietary supplement - no material review
- 21 CFR 111.123(a)(7)Quality control operations - finished batch, specifications
- 21 CFR 111.560(c)Product complaint -investigate, findings, follow-up
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Novis PR, LLC dba Kramer Novis
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2026 | Not classified | San Juan District Office | |
| April 24, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 17, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 15, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Novis PR, LLC dba Kramer Novis
- FDA Inspection 1328054 - 2026-06-30
- FDA Inspection 1203465 - 2023-04-24
- FDA Inspection 976997 - 2016-05-17
- FDA Inspection 680680 - 2010-09-15
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