FDA Inspection
Dharma Research, Inc.Dharma Research, Inc. – FDA Inspection, Nov 23, 2011
Record Details
This FDA Inspection record concerns Dharma Research, Inc., with an inspection on November 23, 2011, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Dharma Research, Inc.
- Inspection Date
- November 23, 2011
- Product Type
- Veterinary
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ID · c5f598b0-ffa9-4e43-a048-f6a6806b290a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754510
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
10- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.198(a)Adverse Drug Experience
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130(d)Examination of packaging and labeling
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Dharma Research, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2026 | VAI | Florida District Office | Compliance: Medical Devices |
| December 11, 2024 | VAI | Florida District Office | Compliance: Medical Devices |
| September 30, 2022 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 18, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 1, 2016 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
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