FDA Inspection
Mankind Pharma LimitedMankind Pharma Limited – FDA Inspection, Jul 12, 2019
Record Details
This FDA Inspection record concerns Mankind Pharma Limited, with an inspection on July 12, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · 939e2363-925d-455a-a1f4-7e5a60c66d49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096969
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.165(e)Test methods
- 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 Mankind Pharma Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Mankind Pharma Limited
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.