FDA Inspection
Dynamit Nobel GmbH Explosivstoff- und SystemtechnikDynamit Nobel GmbH Explosivstoff- und Systemtechnik – FDA Inspection, Dec 7, 2018
Record Details
This FDA Inspection record concerns Dynamit Nobel GmbH Explosivstoff- und Systemtechnik, with an inspection on December 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 7, 2018
- Product Type
- Drugs
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ID · fdf1735d-b547-42b9-a455-09c58368f76a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073746
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 22, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
- FDA Inspection 1272891 - 2023-09-01
- FDA Inspection 970975 - 2016-05-06
- FDA Inspection 845075 - 2013-07-18
- FDA Inspection 585821 - 2009-05-22
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