FDA Inspection
INVITRO RESEARCH SOLUTIONS PRIVATE LIMITEDINVITRO RESEARCH SOLUTIONS PRIVATE LIMITED – FDA Inspection, Dec 18, 2025
Record Details
This FDA Inspection record concerns INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED, with an inspection on December 18, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- December 18, 2025
- Product Type
- Human Drugs
View Company Profile
ID · 2a8f2831-ec71-4659-96ca-7fbab38ea8de
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1295968
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.194(a)Complete test data included in records
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.