FDA Inspection
Shilpa Medicare LimitedShilpa Medicare Limited – FDA Inspection, Feb 13, 2019
Record Details
This FDA Inspection record concerns Shilpa Medicare Limited, with an inspection on February 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · a762f156-536e-49db-b3a7-d36e461a84f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079090
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(a)Lab controls established, including changes
Full citation text and observation details available on the Dashboard.
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.