FDA Inspection
E.A. Beck & Co.E.A. Beck & Co. – FDA Inspection, Aug 25, 2010
Record Details
This FDA Inspection record concerns E.A. Beck & Co., with an inspection on August 25, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- E.A. Beck & Co.
- Inspection Date
- August 25, 2010
- Product Type
- Devices
View Company Profile
ID · 04d6014b-3335-4b65-977c-4e2af9092abb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 677276
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of E.A. Beck & Co.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for E.A. Beck & Co.
- FDA Inspection 1022942 - 2017-08-10
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