FDA Inspection
Calvin Scott & Company, Inc.Calvin Scott & Company, Inc. – FDA Inspection, Dec 2, 2021
Record Details
This FDA Inspection record concerns Calvin Scott & Company, Inc., with an inspection on December 2, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Calvin Scott & Company, Inc.
- Inspection Date
- December 2, 2021
- Product Type
- Drugs
View Company Profile
ID · c360d630-2691-45a0-ada2-1a6fbe1dfc8b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1158271
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 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 211.182Written records kept in individual logs
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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 |
| 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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