FDA Inspection
Kothari Phytochemicals InternationalKothari Phytochemicals International – FDA Inspection, Aug 29, 2025
Record Details
This FDA Inspection record concerns Kothari Phytochemicals International, with an inspection on August 29, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · ede5429b-d1b8-4d3b-8ab4-5bfde4bf5a32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280138
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kothari Phytochemicals International
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 22, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kothari Phytochemicals International
- FDA Inspection 1111221 - 2019-11-08
- FDA Inspection 996110 - 2016-12-09
- FDA Inspection 703177 - 2010-12-22
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.