FDA Inspection
Nano9 Labs, LLCNano9 Labs, LLC – FDA Inspection, Apr 11, 2025
Record Details
This FDA Inspection record concerns Nano9 Labs, LLC, with an inspection on April 11, 2025, issued by the Denver District Office, covering foods & cosmetics.
- Office
- Denver District Office
- People
- Courtney R. Ingalsbe (Issuing Officer)
- Joshua A. Querl (Issuing Officer)
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ID · 470243b0-e637-4b62-af5f-92779a625547
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1261739
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 114.83Scheduled process establishment
- 21 CFR 111.70(b)Specifications - components
- 21 CFR 111.27(b)Instruments - calibration
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(e)Specifications - finished dietary supplement
- 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
- 21 CFR 111.205(a)Master manufacturing record - prepared
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.210Master manufacturing record - record requirements
- 21 CFR 111.105(i)Quality control - required operations
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