FDA Inspection
Sella Natural Cosmetics Co., Ltd.Sella Natural Cosmetics Co., Ltd. – FDA Inspection, Feb 3, 2017
Record Details
This FDA Inspection record concerns Sella Natural Cosmetics Co., Ltd., with an inspection on February 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 861929a3-adfd-4cec-b64c-2329c1cdae3c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005503
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.100(a)Absence of Written Procedures
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