FDA Inspection
Madcar A Division of Century Direct SolutionsMadcar A Division of Century Direct Solutions – FDA Inspection, Dec 20, 2023
Record Details
This FDA Inspection record concerns Madcar A Division of Century Direct Solutions, with an inspection on December 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 20, 2023
- Product Type
- Drugs
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ID · 8ada6225-1cde-48aa-9021-0a58856d2ed7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225785
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
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Other FDA inspections of Madcar A Division of Century Direct Solutions
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 7, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Madcar A Division of Century Direct Solutions
- FDA Inspection 1220666 - 2023-10-05
- FDA Inspection 988731 - 2016-10-17
- FDA Inspection 764009 - 2012-01-23
- FDA Inspection 715338 - 2011-03-18
- FDA Inspection 670866 - 2010-07-07
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