FDA Inspection
IVIMEA LLCIVIMEA LLC – FDA Inspection, Mar 31, 2026
Record Details
This FDA Inspection record concerns IVIMEA LLC, with an inspection on March 31, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · 504b486a-fd2e-4a6f-8545-c2f9d9e80f5c
Inspection Facts
- Inspection number
- 1311588
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
17- 21 CFR 1002.10Failure to submit, distinct marking
- 21 CFR 1002.13Failure to submit
- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.11(a)(3)Aperture label
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 830.310(b)GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.2.5Records of conformity and QMS operations not maintained
- ISO 13485:2016 Clause 5.6.1QMS not reviewed by top management at documented planned intervals
Showing 10 of 17 citations.
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Other FDA inspections of IVIMEA LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2019 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for IVIMEA LLC
- FDA Inspection 1109734 - 2019-06-24
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