FDA Inspection
Aesica Pharmaceuticals GmbHAesica Pharmaceuticals GmbH – FDA Inspection, Jun 20, 2014
Record Details
This FDA Inspection record concerns Aesica Pharmaceuticals GmbH, with an inspection on June 20, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aesica Pharmaceuticals GmbH
- Inspection Date
- June 20, 2014
- Product Type
- Drugs
View Company Profile
ID · f6df76d7-b881-4945-8a88-53c7310b1cf1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887354
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Aesica Pharmaceuticals GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2016 | VAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| November 8, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aesica Pharmaceuticals GmbH
- FDA Inspection 1277716 - 2023-08-31
- FDA Inspection 1105950 - 2019-08-30
- FDA Inspection 994783 - 2016-12-02
- FDA Inspection 759166 - 2011-11-08
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