FDA Inspection
Intercosmetiques SASIntercosmetiques SAS – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns Intercosmetiques SAS, with an inspection on March 3, 2017, covering drugs.
- Company
- Intercosmetiques SAS
- Inspection Date
- March 3, 2017
- Product Type
- Drugs
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ID · 932378ad-9b51-42e5-97fa-e4865cf03fae
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1018593
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.25(a)GMP Training Frequency
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