FDA Inspection
Olgam Life LLCOlgam Life LLC – FDA Inspection, Jan 22, 2026
Record Details
This FDA Inspection record concerns Olgam Life LLC, with an inspection on January 22, 2026, issued by the New York District Office, covering biologics.
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ID · 3f9e3e95-6bdf-4d9c-b9af-5a7657adac7c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1299852
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 600.12(a)Maintenance - tracing
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.40Clean & orderly
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Other FDA inspections of Olgam Life LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2023 | Not classified | New York District Office |
Other documents for Olgam Life LLC
- FDA Inspection 1234056 - 2023-11-14
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