FDA Inspection
Reprolife America, LLCReprolife America, LLC – FDA Inspection, Mar 20, 2026
Record Details
This FDA Inspection record concerns Reprolife America, LLC, with an inspection on March 20, 2026, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 4cbb1488-385e-4858-8610-10d2ead22a4d
Inspection Facts
- Inspection number
- 1308266
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
10- ISO 13485:2016 Clause 4.1.1QMS not documented and maintained adequately
- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
- ISO 13485:2016 Clause 7.3.9Significance of design and development changes not determined
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 7.5.9.1Procedures for traceability were not documented
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