FDA Inspection
Lingraphicare America, Inc.Lingraphicare America, Inc. – FDA Inspection, Feb 15, 2017
Record Details
This FDA Inspection record concerns Lingraphicare America, Inc., with an inspection on February 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c0c4ea2f-122a-4fa2-8c7e-69e0f779a11e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1002305
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(e)Documentation
Full citation text and observation details available on the Dashboard.
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 |
| June 24, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 883463 - 2014-06-24
- FDA Inspection 759639 - 2011-12-21
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