FDA Inspection
Kabana Skin CareKabana Skin Care – FDA Inspection, Feb 20, 2025
Record Details
This FDA Inspection record concerns Kabana Skin Care, with an inspection on February 20, 2025, issued by the Denver District Office, covering human drugs.
- Office
- Denver District Office
- Person
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ID · 6b2cc781-1a44-4bd5-b908-dbb01678b1d0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1261682
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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