FDA Inspection
Haute Health, LLCHaute Health, LLC – FDA Inspection, Sep 25, 2013
Record Details
This FDA Inspection record concerns Haute Health, LLC, with an inspection on September 25, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Haute Health, LLC
- Inspection Date
- September 25, 2013
- Product Type
- Drugs
View Company Profile
ID · f87c632e-92ee-4e5b-bc69-7ed81f3f364e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848492
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
8- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.8Written procedures - personnel qualifications
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.13(a)Supervisor - qualified
- 21 CFR 111.12(b)Personnel - quality control operations; identified
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