FDA Inspection
Dolphin LifeScience India LLPDolphin LifeScience India LLP – FDA Inspection, Jan 30, 2025
Record Details
This FDA Inspection record concerns Dolphin LifeScience India LLP, with an inspection on January 30, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 30, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 57ccecd0-068f-4cc5-bb4d-14d66ceff33d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1259490
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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.