FDA Inspection
Losan Pharma GmbHLosan Pharma GmbH – FDA Inspection, Jun 20, 2013
Record Details
This FDA Inspection record concerns Losan Pharma GmbH, with an inspection on June 20, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Losan Pharma GmbH
- Inspection Date
- June 20, 2013
- Product Type
- Drugs
View Company Profile
ID · 1d0f6650-1541-45c1-9cac-d05cd99b8d26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836631
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Losan Pharma GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 20, 2023 | Not classified | Office of Inspections and Investigations | |
| April 15, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 24, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Losan Pharma GmbH
- FDA Inspection 1320512 - 2023-07-20
- FDA Inspection 1161247 - 2021-04-15
- FDA Inspection 932814 - 2015-06-24
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