FDA Inspection
Lingraphicare America, Inc.Lingraphicare America, Inc. – FDA Inspection, Apr 15, 2009
Record Details
This FDA Inspection record concerns Lingraphicare America, Inc., with an inspection on April 15, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lingraphicare America, Inc.
- Inspection Date
- April 15, 2009
- Product Type
- Devices
View Company Profile
ID · 95a9b899-4416-4ec5-a543-0ae941347968
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 572939
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.198(a)General
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.184(d)Acceptance records
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Lingraphicare America, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2025 | VAI | New Jersey District Office | Compliance: Medical Devices |
| August 4, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Lingraphicare America, Inc.
- FDA Inspection 1261187 - 2025-02-03
- FDA Inspection 1177262 - 2022-08-04
- FDA Inspection 1109991 - 2019-11-15
- FDA Inspection 1002305 - 2017-02-15
- FDA Inspection 883463 - 2014-06-24
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