FDA Inspection
Pausch LLCPausch LLC – FDA Inspection, Mar 23, 2026
Record Details
This FDA Inspection record concerns Pausch LLC, with an inspection on March 23, 2026, issued by the New Jersey District Office, covering medical devices & rad health.
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ID · a7da0afd-bf72-46b0-a17b-b36ad5d7c6dd
Inspection Facts
- Inspection number
- 1308682
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 5.6.1QMS not reviewed by top management at documented planned intervals
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Pausch LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pausch LLC
- FDA Inspection 1190465 - 2022-11-09
- FDA Inspection 757196 - 2011-12-14
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