FDA Inspection
ProThera, Inc. dba SFI USAProThera, Inc. dba SFI USA – FDA Inspection, Nov 7, 2018
Record Details
This FDA Inspection record concerns ProThera, Inc. dba SFI USA, with an inspection on November 7, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · d7895999-3844-4468-865e-170a22f0273b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071186
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.113Quality control operations - material review, disposition
- 21 CFR 111.20(d)(1)(i)Floors, walls, ceilings
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ProThera, Inc. dba SFI USA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2023 | Not classified | San Francisco District Office | |
| October 30, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 16, 2013 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for ProThera, Inc. dba SFI USA
- FDA Inspection 1206125 - 2023-04-25
- FDA Inspection 947258 - 2015-10-30
- FDA Inspection 840787 - 2013-07-16
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