FDA Inspection
ASEPTIKITS, LLCASEPTIKITS, LLC – FDA Inspection, Dec 3, 2025
Record Details
This FDA Inspection record concerns ASEPTIKITS, LLC, with an inspection on December 3, 2025, issued by the Denver District Office, covering medical devices & rad health.
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ID · aead7cb3-b0cc-4aa1-8a1c-cdf083c2648d
Inspection Facts
- Inspection number
- 1288994
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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