FDA Inspection
Lingraphicare America, Inc.Lingraphicare America, Inc. – FDA Inspection, Feb 3, 2025
Record Details
This FDA Inspection record concerns Lingraphicare America, Inc., with an inspection on February 3, 2025, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- Lingraphicare America, Inc.
- Inspection Date
- February 3, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · bfb10226-9c1d-4dd0-b23d-bf3d1a8463bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1261187
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lingraphicare America, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| December 21, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lingraphicare America, Inc.
- FDA Inspection 1177262 - 2022-08-04
- FDA Inspection 1109991 - 2019-11-15
- FDA Inspection 1002305 - 2017-02-15
- FDA Inspection 883463 - 2014-06-24
- FDA Inspection 759639 - 2011-12-21
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