Sarah M. Gauna
FDA investigator
Appears on 4 documents from 2025 to 2026, most often at sites in Florida. Most often cites design and construction features (21 CFR 211.42).
- 4
- Documents on file
- 9.0
- Observations per 483
- 2025
- First seen
- 2026
- Most recent
What they cite most
From 36 observations- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
Activity by year
2025: 3, 2026: 1
Where
Florida 1 · Minnesota 1 · Missouri 1 · North Carolina 1
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-08-12 | 483 IntegraDose Compound ing Services LLCAug 12, 2026 · Shoreview, Minnesota | Shoreview, Minnesota | 4 | |
| 2025-09-23 | 483 Park Avenue CompoundingSep 23, 2025 · Saint Louis, Missouri | Saint Louis, Missouri | 8 | |
| 2025-07-18 | 483 GenoGeni xJul 18, 2025 · Boca Raton, Florida | Boca Raton, Florida | 16 | |
| 2025-05-15 | 483 Apothecary Pharma LLCMay 15, 2025 · Cary, North Carolina | Cary, North Carolina | 8 |
About this profile
What does Sarah M. Gauna inspect?
Sarah M. Gauna appears on 4 documents on file covering 4 sites, most often in Florida.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.113 and 21 CFR 211.192.
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 Sarah M. Gauna is dated Aug 12, 2026.