FDA Inspection
Cramer Products IncCramer Products Inc – FDA Inspection, Apr 14, 2017
Record Details
This FDA Inspection record concerns Cramer Products Inc, with an inspection on April 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3b99d158-cd06-4788-a845-0793ae774fd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009621
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 211.68(a)Written calibration / inspection records not kept
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Other FDA inspections of Cramer Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| January 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cramer Products Inc
- FDA Inspection 946520 - 2015-10-26
- FDA Inspection 755637 - 2011-12-05
- FDA Inspection 645205 - 2010-01-20
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