FDA Inspection
Cramer Products IncCramer Products Inc – FDA Inspection, Jan 20, 2010
Record Details
This FDA Inspection record concerns Cramer Products Inc, with an inspection on January 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cramer Products Inc
- Inspection Date
- January 20, 2010
- Product Type
- Devices
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ID · c9510d67-c1bf-497e-8406-a18cf3942ca3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645205
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 820.160(a)Control/distribution procedures
- 21 CFR 820.184(f)Device identification, control numbers
- 21 CFR 211.186(b)(4)Variation in the Amount of Components Used
- 21 CFR 820.20(a)Quality policy and objectives
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Other FDA inspections of Cramer Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 26, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 5, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cramer Products Inc
- FDA Inspection 1009621 - 2017-04-14
- FDA Inspection 946520 - 2015-10-26
- FDA Inspection 755637 - 2011-12-05
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