FDA Inspection
Schrofner Cosmetics GmbhSchrofner Cosmetics Gmbh – FDA Inspection, Jul 19, 2017
Record Details
This FDA Inspection record concerns Schrofner Cosmetics Gmbh, with an inspection on July 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 578580bd-f2e9-4ba8-b6f9-9006dc816895
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1021292
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
33- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 211.170(a)Active ingredient retained sample kept
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
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