FDA Inspection
Calvin Scott & Company, Inc.Calvin Scott & Company, Inc. – FDA Inspection, Jun 18, 2021
Record Details
This FDA Inspection record concerns Calvin Scott & Company, Inc., with an inspection on June 18, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Calvin Scott & Company, Inc.
- Inspection Date
- June 18, 2021
- Product Type
- Drugs
View Company Profile
ID · 75a71ccb-f587-4649-a2f6-728a6d9b184f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1144336
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 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 211.100(a)Absence of Written Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Calvin Scott & Company, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2021 | OAI | 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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