FDA Inspection
Les Emballages Facoteck IncLes Emballages Facoteck Inc – FDA Inspection, Dec 1, 2017
Record Details
This FDA Inspection record concerns Les Emballages Facoteck Inc, with an inspection on December 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4de78c76-4bae-4652-b5f1-a21a19741504
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1032573
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.170(a)(1)Retention time for reserve samples of actives
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures not established/followed
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