FDA Inspection
Vetter Pharma Fertigung GmbH & Co. KGVetter Pharma Fertigung GmbH & Co. KG – FDA Inspection, Apr 26, 2016
Record Details
This FDA Inspection record concerns Vetter Pharma Fertigung GmbH & Co. KG, with an inspection on April 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 26, 2016
- Product Type
- Drugs
View Company Profile
ID · 0ec689ff-3e00-4d1b-93eb-04ba44856bc9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1001330
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Vetter Pharma Fertigung GmbH & Co. KG
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2024 | Not classified | Office of Inspections and Investigations | |
| February 24, 2023 | Not classified | Office of Inspections and Investigations | |
| May 24, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Vetter Pharma Fertigung GmbH & Co. KG
- FDA Inspection 1234265 - 2024-04-24
- FDA Inspection 1201723 - 2023-02-24
- FDA Inspection 1205983 - 2022-05-24
- FDA Inspection 1129699 - 2019-09-13
- FDA Inspection 1070717 - 2018-09-21
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