Irina Gaberman
FDA investigator
Appears on 8 documents from 2011 to 2025, most often at sites in New York. Most often cites written procedures; deviations (21 CFR 211.100).
- 8
- Documents on file
- 6.8
- Observations per 483
- 2011
- First seen
- 2025
- Most recent
What they cite most
From 54 observations- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements4
- 21 CFR 1271.60What quarantine and other requirements apply before the donor-eligibility determination is complete?3
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.67Equipment cleaning and maintenance3
Activity by year
2011: 1, 2017: 1, 2020: 1, 2023: 2, 2024: 2, 2025: 1
Where
New York 3 · Japan 1 · New Jersey 1 · Spain 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-11-17 | 483 Americord Registry LLCNov 17, 2025 · Somerset, New Jersey | Somerset, New Jersey | 17 | |
| 2024-07-26 | 483 FDA Form 438 Grifols, Barcelona, Spain, July 2024Jul 26, 2024 · Paret s Del Valles | Paret s Del Valles | 4 | |
| 2024-07-26 | 483 Laboratorios Grifols, S.A.Jul 26, 2024 · Parets del Valles, Spain | Parets del Valles, Spain | 4 | |
| 2023-05-19 | 483 FDA Form 483 FUJINOMIYA FACTORY OF TERUMO CORP Fujinomiya, Japan May 2023May 19, 2023 · Fujinomiya, Japan | Fujinomiya, Japan | 6 | |
| 2023-05-12 | 483 Form 483, May 12, 2023May 12, 2023 | — | 2 | |
| 2020-02-11 | 483 New York Blood Center, Inc.Feb 11, 2020 · Rye, New York | Rye, New York | 4 | |
| 2017-09-29 | 483 New York Blood Center, Inc.Sep 29, 2017 · Rye, New York | Rye, New York | 4 |
About this profile
What does Irina Gaberman inspect?
Irina Gaberman appears on 8 documents on file covering 4 sites, most often in New York.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.160 and 21 CFR 1271.60.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Irina Gaberman is dated Nov 17, 2025.