FDA Inspection
Hameln RDS S.R.O.Hameln RDS S.R.O. – FDA Inspection, Apr 22, 2016
Record Details
This FDA Inspection record concerns Hameln RDS S.R.O., with an inspection on April 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hameln RDS S.R.O.
- Inspection Date
- April 22, 2016
- Product Type
- Drugs
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ID · aed624e6-296f-43bd-83aa-b2e4685671b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969056
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Hameln RDS S.R.O.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 1, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hameln RDS S.R.O.
- FDA Inspection 1239846 - 2024-04-26
- FDA Inspection 800975 - 2012-08-01
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