FDA Inspection
Dixon Investments IncDixon Investments Inc – FDA Inspection, Mar 11, 2025
Record Details
This FDA Inspection record concerns Dixon Investments Inc, with an inspection on March 11, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · 91961a19-5a06-4d00-8690-898dde318914
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1263416
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dixon Investments Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dixon Investments Inc
- FDA Inspection 1083739 - 2019-03-22
- FDA Inspection 956550 - 2015-12-16
- FDA Inspection 858354 - 2013-12-06
- FDA Inspection 758691 - 2011-12-13
- FDA Inspection 646629 - 2010-01-25
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