FDA Inspection
Coral Drugs Private LimitedCoral Drugs Private Limited – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Coral Drugs Private Limited, with an inspection on February 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · dce94dfb-a69f-4926-a029-5831e52091ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041963
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.80(a)Written Procedures Not Followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Coral Drugs Private Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2025 | Not classified | Office of Inspections and Investigations | |
| December 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 13, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Coral Drugs Private Limited
- FDA Inspection 1266199 - 2025-04-08
- FDA Inspection 1155291 - 2019-12-11
- FDA Inspection 961256 - 2016-03-11
- FDA Inspection 703541 - 2010-11-13
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.