FDA Inspection
American Softgels, Inc.American Softgels, Inc. – FDA Inspection, Feb 26, 2024
Record Details
This FDA Inspection record concerns American Softgels, Inc., with an inspection on February 26, 2024, issued by the Philadelphia District Office, covering foods & cosmetics.
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ID · a018b24e-a824-4b6a-80a8-4970f96a9b06
Inspection Facts
- Inspection number
- 1231005
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.113(a)(3)Quality control - adulteration; material review, disposition
- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(d)Specifications - labels, packaging
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Other FDA inspections of American Softgels, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2024 | VAI | Philadelphia District Office | Food Composition, Standards, Labeling, and Economics |
| April 27, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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