FDA Inspection
Laboratoires DelonLaboratoires Delon – FDA Inspection, Feb 21, 2025
Record Details
This FDA Inspection record concerns Laboratoires Delon, with an inspection on February 21, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 98e3c4bc-2efb-4bb7-acc8-a451078d52e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1262809
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Laboratoires Delon
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratoires Delon
- FDA Inspection 1116000 - 2020-01-24
- FDA Inspection 997025 - 2016-12-09
- FDA Inspection 906587 - 2014-11-07
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