FDA Inspection
Novis PR, LLC dba Kramer NovisFDA Inspection 1203465 - Novis PR, LLC dba Kramer Novis - April 24, 2023
Record Details
This FDA Inspection record concerns Novis PR, LLC dba Kramer Novis, with an inspection on April 24, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 21bb116c-75ba-4f15-9783-eea21290b348
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203465
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 111.105Quality control - ensure quality; package, labeled, master record
- 21 CFR 111.105Quality control - ensure quality; package, labeled, master record
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 | |
| June 13, 2019 | 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 1093190 - 2019-06-13
- FDA Inspection 976997 - 2016-05-17
- FDA Inspection 680680 - 2010-09-15
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