FDA Inspection
American Softgels, Inc.American Softgels, Inc. – FDA Inspection, Apr 27, 2023
Record Details
This FDA Inspection record concerns American Softgels, Inc., with an inspection on April 27, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
View Company Profile
ID · 8f11624d-48f1-4d03-9f4f-1fc73b660b8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203838
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
43- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 111.180(b)(3)(i)Document - required operation
- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.16Written procedures - cleaning
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
Showing 10 of 43 citations.
Full citation text and observation details available on the Dashboard.
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 |
| February 26, 2024 | Not classified | Philadelphia District Office | Food Composition, Standards, Labeling and Econ |
Other documents for American Softgels, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.