FDA Inspection
Groupe Marcelle Inc.Groupe Marcelle Inc. – FDA Inspection, Dec 8, 2017
Record Details
This FDA Inspection record concerns Groupe Marcelle Inc., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 288ede7f-f5aa-43e5-bbfe-2bacbe722b87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034256
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.182Written records kept in individual logs
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