FDA Inspection
Alphapharm Pty, Ltd.Alphapharm Pty, Ltd. – FDA Inspection, Jun 28, 2024
Record Details
This FDA Inspection record concerns Alphapharm Pty, Ltd., with an inspection on June 28, 2024, covering drugs.
- Company
- Alphapharm Pty, Ltd.
- Inspection Date
- June 28, 2024
- Product Type
- Drugs
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ID · b14212c3-baf0-4807-9fd7-7db37381063b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1238748
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Alphapharm Pty, Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 24, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alphapharm Pty, Ltd.
- FDA Inspection 1236816 - 2024-05-03
- FDA Inspection 1111818 - 2019-10-24
- FDA Inspection 1029077 - 2017-09-15
- FDA Inspection 936225 - 2015-07-02
- FDA Inspection 844498 - 2013-07-18
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