FDA Inspection
Iruri Nature Handmade Soap & Cosmetic IncIruri Nature Handmade Soap & Cosmetic Inc – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Iruri Nature Handmade Soap & Cosmetic Inc, with an inspection on November 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4c13f9e1-8801-4907-acd9-69dc9a9e8c36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1071871
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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