FDA Inspection
Telix IsoTherapeutics Group, Inc.Telix IsoTherapeutics Group, Inc. – FDA Inspection, May 17, 2019
Record Details
This FDA Inspection record concerns Telix IsoTherapeutics Group, Inc., with an inspection on May 17, 2019, issued by the Dallas District Office, covering human drugs.
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ID · 66f046d1-c165-497a-b926-5a9a84ef4670
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089897
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Telix IsoTherapeutics Group, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2025 | VAI | Dallas District Office | Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| February 3, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 30, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Telix IsoTherapeutics Group, Inc.
- FDA Inspection 1277105 - 2025-07-31
- FDA Inspection 1117578 - 2020-02-03
- FDA Inspection 994402 - 2016-11-30
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