FDA Inspection
KSE Scientific LLCKSE Scientific LLC – FDA Inspection, Apr 30, 2024
Record Details
This FDA Inspection record concerns KSE Scientific LLC, with an inspection on April 30, 2024, issued by the Atlanta District Office, covering medical devices & rad health.
View Company Profile
ID · e6e5414b-0e48-4922-8617-36838284b220
Inspection Facts
- Inspection number
- 1233655
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.