FDA Inspection
allphamed PHARBIL Arzneimittel GmbHallphamed PHARBIL Arzneimittel GmbH – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns allphamed PHARBIL Arzneimittel GmbH, with an inspection on July 12, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 7dc2a2ba-7200-4939-b38c-997d75744ad5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096510
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188(b)(4)Weights and Measures of Components Used
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
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Other FDA inspections of allphamed PHARBIL Arzneimittel GmbH
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2024 | VAI | Drug Quality Assurance | |
| October 1, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for allphamed PHARBIL Arzneimittel GmbH
- FDA Inspection 1305638 - 2024-11-19
- FDA Inspection 1140527 - 2020-10-01
- FDA Inspection 1030230 - 2017-09-29
- FDA Inspection 935795 - 2015-07-10
- FDA Inspection 894011 - 2014-09-05
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