FDA Inspection
Carib Supply of St. Croix, Inc.Carib Supply of St. Croix, Inc. – FDA Inspection, Dec 21, 2011
Record Details
This FDA Inspection record concerns Carib Supply of St. Croix, Inc., with an inspection on December 21, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 21, 2011
- Product Type
- Drugs
View Company Profile
ID · e2290648-720d-417e-a94d-a4422aff6d85
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 760099
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carib Supply of St. Croix, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 6, 2008 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Carib Supply of St. Croix, Inc.
- FDA Inspection 906153 - 2014-12-05
- FDA Inspection 799143 - 2012-09-13
- FDA Inspection 564922 - 2009-02-18
- FDA Inspection 555492 - 2008-10-06
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