FDA Inspection
Eriochem SAEriochem SA – FDA Inspection, Nov 5, 2019
Record Details
This FDA Inspection record concerns Eriochem SA, with an inspection on November 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Eriochem SA
- Inspection Date
- November 5, 2019
- Product Type
- Drugs
View Company Profile
ID · 7e2ad690-aa4c-495f-ba45-cf9dbf978fed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1108777
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
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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 | |
| May 22, 2018 | 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 1052832 - 2018-05-22
- FDA Inspection 1002604 - 2016-11-23
- FDA Inspection 963248 - 2016-03-03
- FDA Inspection 886207 - 2014-06-03
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