FDA Inspection 1330542 — Superior Labs Inc
The FDA completed an inspection of Superior Labs Inc on Aug 11, 2026 in Charlotte, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23086 | ISO 13485:2016 Clause 7.1 | Planning of product realization not consistent with other QMS processes |
| 23099 | ISO 13485:2016 Clause 7.3.2 | Design and development of product not planned and controlled |
| 23154 | ISO 13485:2016 Clause 7.4.3 | Records of purchased product verification not maintained |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23200 | ISO 13485:2016 Clause 7.6 | Equipment calibration or verification not performed |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23267 | 21 CFR 820.35(c) | UDI was not recorded for each medical device or batch |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |