FDA Inspection
Laboratorio Echevarne SALaboratorio Echevarne SA – FDA Inspection, Jan 29, 2022
Record Details
This FDA Inspection record concerns Laboratorio Echevarne SA, with an inspection on January 29, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratorio Echevarne SA
- Inspection Date
- January 29, 2022
- Product Type
- Drugs
View Company Profile
ID · d917ba25-c03c-4a89-98d1-f55e49059f2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1161833
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Laboratorio Echevarne SA
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 24, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 17, 2013 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| March 3, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorio Echevarne SA
- FDA Inspection 1090077 - 2018-04-12
- FDA Inspection 866378 - 2014-01-24
- FDA Inspection 848462 - 2013-09-17
- FDA Inspection 580044 - 2009-03-03
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