FDA Inspection
First Source Laboratory Solutions LLPFirst Source Laboratory Solutions LLP – FDA Inspection, Feb 16, 2024
Record Details
This FDA Inspection record concerns First Source Laboratory Solutions LLP, with an inspection on February 16, 2024, issued by the Center for Drug Evaluation and Research.
- Inspection Date
- February 16, 2024
View Company Profile
ID · b05cc7a3-5d37-4d6c-a023-a25519cec939
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230226
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
FDA Citations
3- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of First Source Laboratory Solutions LLP
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for First Source Laboratory Solutions LLP
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.