FDA Inspection
Biocosmetica Excel Argentina S.R.L.Biocosmetica Excel Argentina S.R.L. – FDA Inspection, Jul 7, 2022
Record Details
This FDA Inspection record concerns Biocosmetica Excel Argentina S.R.L., with an inspection on July 7, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 7, 2022
- Product Type
- Drugs
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ID · f5d90d8c-4c21-411d-88fe-df2b67a01257
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1173827
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Biocosmetica Excel Argentina S.R.L.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 10, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Biocosmetica Excel Argentina S.R.L.
- FDA Inspection 963681 - 2016-03-10
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