FDA Inspection
3M Espe Dental Products3M Espe Dental Products – FDA Inspection, Mar 13, 2009
Record Details
This FDA Inspection record concerns 3M Espe Dental Products, with an inspection on March 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- 3M Espe Dental Products
- Inspection Date
- March 13, 2009
- Product Type
- Drugs
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ID · 7118c5d6-dd0c-476b-9843-545ad5a31b4c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579363
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of 3M Espe Dental Products
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 19, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for 3M Espe Dental Products
- FDA Inspection 1046452 - 2018-03-07
- FDA Inspection 872250 - 2014-03-12
- FDA Inspection 799456 - 2012-09-20
- FDA Inspection 698056 - 2010-11-19
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