FDA Inspection
Bio Protech, Inc.Bio Protech, Inc. – FDA Inspection, Apr 9, 2026
Record Details
This FDA Inspection record concerns Bio Protech, Inc., with an inspection on April 9, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 0b641380-81ac-481c-b13a-5eb41add8c69
Inspection Facts
- Inspection number
- 1318198
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 6.4.1(a)Requirements for personnel health, cleanliness, and clothing not documented
- ISO 13485:2016 Clause 7.5.7Processes for sterilization and sterile barrier systems not validated
- ISO 13485:2016 Clause 8.2.5Monitoring/measurement methods do not show QMS processes meet planned results
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Other FDA inspections of Bio Protech, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 9, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bio Protech, Inc.
- FDA Inspection 977719 - 2016-03-23
- FDA Inspection 704336 - 2010-12-09
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