FDA Inspection
Creative Technologies, IncCreative Technologies, Inc – FDA Inspection, Jan 12, 2012
Record Details
This FDA Inspection record concerns Creative Technologies, Inc, with an inspection on January 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Creative Technologies, Inc
- Inspection Date
- January 12, 2012
- Product Type
- Drugs
View Company Profile
ID · b8e54967-453c-40d7-894e-fa1b514f81da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 760326
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Creative Technologies, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Creative Technologies, Inc
- FDA Inspection 910906 - 2015-01-22
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