FDA Inspection
Telix IsoTherapeutics Group, Inc.Telix IsoTherapeutics Group, Inc. – FDA Inspection, Jul 31, 2025
Record Details
This FDA Inspection record concerns Telix IsoTherapeutics Group, Inc., with an inspection on July 31, 2025, issued by the Dallas District Office, covering animal drugs & feeds.
- Inspection Date
- July 31, 2025
- Product Type
- Animal Drugs & Feeds
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ID · 00ed8c68-0d69-4e9f-a178-27095a6fa684
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277105
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feeds, and Devices
FDA Citations
10- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Backup data not assured as exact and complete
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Other FDA inspections of Telix IsoTherapeutics Group, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2019 | VAI | Dallas District Office | Generic Drug Evaluation |
| November 30, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Telix IsoTherapeutics Group, Inc.
- FDA Inspection 1117578 - 2020-02-03
- FDA Inspection 1089897 - 2019-05-17
- FDA Inspection 994402 - 2016-11-30
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