FDA Inspection
Newpharma, Inc.Newpharma, Inc. – FDA Inspection, Mar 15, 2019
Record Details
This FDA Inspection record concerns Newpharma, Inc., with an inspection on March 15, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 06a5b571-e9ea-4e23-bd0d-a60fe1bca493
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1082697
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.105(b)Quality control - supplier qualification
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Other FDA inspections of Newpharma, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 28, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 22, 2011 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| April 15, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Newpharma, Inc.
- FDA Inspection 1242998 - 2024-07-01
- FDA Inspection 976250 - 2016-06-28
- FDA Inspection 712965 - 2011-02-22
- FDA Inspection 576566 - 2009-04-15
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