FDA Inspection
Weleda AGWeleda AG – FDA Inspection, Apr 12, 2012
Record Details
This FDA Inspection record concerns Weleda AG, with an inspection on April 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Weleda AG
- Inspection Date
- April 12, 2012
- Product Type
- Drugs
View Company Profile
ID · 8523940b-b00c-436c-8e08-7063620b25e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794146
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Weleda AG
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 21, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 10, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Weleda AG
- FDA Inspection 1290150 - 2024-07-17
- FDA Inspection 1154630 - 2019-11-21
- FDA Inspection 1061389 - 2018-06-15
- FDA Inspection 978925 - 2016-06-10
- FDA Inspection 776626 - 2012-03-13
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