FDA Inspection
Almirall Hermal GmbHAlmirall Hermal GmbH – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Almirall Hermal GmbH, with an inspection on March 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7eaa2076-6b92-43bf-9bd5-25c82ca8f245
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086417
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)(4)Complete Test Data
- 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 not established/followed
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Other FDA inspections of Almirall Hermal GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Almirall Hermal GmbH
- FDA Inspection 1270072 - 2021-05-06
- FDA Inspection 898000 - 2014-09-26
- FDA Inspection 779008 - 2012-04-13
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