FDA Inspection 1311588 — IVIMEA LLC
The FDA completed an inspection of IVIMEA LLC on Mar 31, 2026 in Pennington, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 17 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 31, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pennington, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22801 | 21 CFR 830.310(b) | GUDID Information required for unique device identification. |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23043 | ISO 13485:2016 Clause 4.2.5 | Records of conformity and QMS operations not maintained |
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23126 | ISO 13485:2016 Clause 7.3.7 | Records of design and development validation not maintained |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23194 | ISO 13485:2016 Clause 7.6(a) | Measuring equipment not adequately calibrated or verified |
| 23263 | 21 CFR 820.35(a) | Records for complaints involving failure to meet specifications not maintained |
| 23267 | 21 CFR 820.35(c) | UDI was not recorded for each medical device or batch |
| 23270 | 21 CFR 820.45(b) | Release of labeling for use not documented |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |