FDA Inspection
Calvin Scott & Company, Inc.Calvin Scott & Company, Inc. – FDA Inspection, Jun 19, 2023
Record Details
This FDA Inspection record concerns Calvin Scott & Company, Inc., with an inspection on June 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3da7c25f-9f58-4233-81b6-4250d584e58d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208469
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Calvin Scott & Company, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 12, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 25, 2014 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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