FDA Inspection
Almil Nutritional Products IncAlmil Nutritional Products Inc – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Almil Nutritional Products Inc, with an inspection on June 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · acf3e004-b85f-4b2d-ad5c-e30cfebc7bb1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014452
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Almil Nutritional Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2017 | Not classified | Los Angeles District Office | |
| March 7, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 9, 2010 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Almil Nutritional Products Inc
- FDA Inspection 1025710 - 2017-08-30
- FDA Inspection 769967 - 2012-03-07
- FDA Inspection 676081 - 2010-08-09
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