FDA Inspection
Fortune Pharmacal Company LtdFortune Pharmacal Company Ltd – FDA Inspection, Jun 6, 2025
Record Details
This FDA Inspection record concerns Fortune Pharmacal Company Ltd, with an inspection on June 6, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · f67a23c4-d91b-43f1-bdec-7388b34adde1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1274836
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fortune Pharmacal Company Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fortune Pharmacal Company Ltd
- FDA Inspection 1059826 - 2018-07-13
- FDA Inspection 895965 - 2014-08-29
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.