FDA Inspection
East Coast Surgical, Inc.East Coast Surgical, Inc. – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns East Coast Surgical, Inc., with an inspection on August 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ce9cf4b1-e81d-4f61-a5bb-e6ee63176c3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023267
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of East Coast Surgical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for East Coast Surgical, Inc.
- FDA Inspection 1088944 - 2019-03-22
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