FDA Inspection 1308682 — Accogent Pausch
The FDA completed an inspection of Accogent Pausch on Mar 23, 2026 in Tinton Falls, NJ. 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 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tinton Falls, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |