Shannon L. Maisano
FDA investigator
Appears on 3 documents from 2025, mostly at sites in Indiana. Most often cites production record review (21 CFR 211.192).
- 3
- Documents on file
- 6.3
- Observations per 483
- 2025
- First seen
- 2025
- Most recent
What they cite most
From 19 observations- 21 CFR 211.192Production record review3
- 21 CFR 211.166(a)Stability testing2
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
Activity by year
2025: 3
Where
Indiana 2 · Michigan 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-07-25 | 483 Labcorp Early Development LaboratoriesJul 25, 2025 · Greenfield, Indiana | Greenfield, Indiana | 4 | |
| 2025-07-14 | 483 Catalent Indiana LLCJul 14, 2025 · Bloomington, Indiana | Bloomington, Indiana | 6 | |
| 2025-04-03 | 483 Kath Khemicals LLCApr 3, 2025 · Macomb, Michigan | Macomb, Michigan | 9 |
About this profile
What does Shannon L. Maisano inspect?
Shannon L. Maisano appears on 3 documents on file covering 3 sites, mostly in Indiana.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.166(a) and 21 CFR 211.188.
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 Shannon L. Maisano is dated Jul 25, 2025.