FDA Inspection
Argenta Dundee LimitedArgenta Dundee Limited – FDA Inspection, Aug 4, 2009
Record Details
This FDA Inspection record concerns Argenta Dundee Limited, with an inspection on August 4, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Argenta Dundee Limited
- Inspection Date
- August 4, 2009
- Product Type
- Drugs
View Company Profile
ID · 4e22786c-ff9e-448c-9483-71309b54ed46
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610288
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Argenta Dundee Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 28, 2018 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 22, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 24, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Argenta Dundee Limited
- FDA Inspection 1290816 - 2025-06-05
- FDA Inspection 1169522 - 2022-01-20
- FDA Inspection 1071328 - 2018-06-28
- FDA Inspection 971658 - 2016-04-22
- FDA Inspection 821182 - 2013-01-24
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