FDA Inspection 1307158 — WORLD SOURCE SIMPLE LLC
The FDA completed an inspection of WORLD SOURCE SIMPLE LLC on Mar 10, 2026 in Lima, OH. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lima, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23049 | ISO 13485:2016 Clause 5.1 | Lack of evidence for top management's commitment to QMS |
| 23069 | ISO 13485:2016 Clause 6.2 | Personnel competency not adequate |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |