FDA Inspection
Dharma Research, Inc.Dharma Research, Inc. – FDA Inspection, Nov 1, 2016
Record Details
This FDA Inspection record concerns Dharma Research, Inc., with an inspection on November 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 6b6f93aa-4596-4de4-87b6-8e12798ed788
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993004
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
Full citation text and observation details available on the Dashboard.
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 |
| September 12, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dharma Research, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.