FDA Inspection
Calvin Scott & Company, Inc.Calvin Scott & Company, Inc. – FDA Inspection, Mar 12, 2020
Record Details
This FDA Inspection record concerns Calvin Scott & Company, Inc., with an inspection on March 12, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Calvin Scott & Company, Inc.
- Inspection Date
- March 12, 2020
- Product Type
- Drugs
View Company Profile
ID · 2200d359-b4a5-4966-9c9d-9f239059313f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1120650
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.28(d)Excluding Employees with Illness, Lesions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.134(b)Representative samples after completion
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 11 citations.
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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 |
| June 18, 2021 | VAI | 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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