FDA Inspection
Eriochem SAEriochem SA – FDA Inspection, May 22, 2018
Record Details
This FDA Inspection record concerns Eriochem SA, with an inspection on May 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f9cae902-c6f4-418d-aa03-2f96c90895dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052832
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)Defined areas of adequate size for operations
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Other FDA inspections of Eriochem SA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2026 | Not classified | Office of Inspections and Investigations | |
| November 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 23, 2016 | Not classified | Office of Inspections and Investigations | |
| March 3, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 3, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eriochem SA
- FDA Inspection 1322748 - 2026-05-08
- FDA Inspection 1108777 - 2019-11-05
- FDA Inspection 1002604 - 2016-11-23
- FDA Inspection 963248 - 2016-03-03
- FDA Inspection 886207 - 2014-06-03
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