FDA Inspection
Dharma Research, Inc.Dharma Research, Inc. – FDA Inspection, Aug 28, 2009
Record Details
This FDA Inspection record concerns Dharma Research, Inc., with an inspection on August 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dharma Research, Inc.
- Inspection Date
- August 28, 2009
- Product Type
- Drugs
View Company Profile
ID · 07fa6c93-a151-4f8b-ba32-b5d546bf3098
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612763
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)(7)Quarantined Drug Products Area
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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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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