Erik W. Koester
FDA investigator
Appears on 40 documents from 2006 to 2026, mostly at sites in Massachusetts. Most often cites design and construction features (21 CFR 211.42).
- 40
- Documents on file
- 5.1
- Observations per 483
- 2006
- First seen
- 2026
- Most recent
What they cite most
From 198 observations- 21 CFR 211.42Design and construction features22
- 21 CFR 211.67Equipment cleaning and maintenance19
- 21 CFR 211.192Production record review18
- 21 CFR 211.22Responsibilities of quality control unit15
- 21 CFR 211.68Automatic, mechanical, and electronic equipment14
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures13
Activity by year
2006: 1, 2015: 1, 2016: 2, 2017: 8, 2018: 2, 2019: 3, 2020: 3, 2021: 1, 2022: 7, 2023: 6, 2024: 4, 2025: 1, 2026: 1
Where
Massachusetts 21 · Connecticut 3 · New York 3 · Australia 2 · Maine 2 · New Hampshire 2
Often inspects with
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Inspection history
40 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-06-15 | 483 Fayetteville VA Medical Cent erJun 15, 2026 · Fayetteville, North Carolina | Fayetteville, North Carolina | 3 | |
| 2025-08-08 | 483 Hikma Injectables USA IncAug 8, 2025 · Dayton, New Jersey | Dayton, New Jersey | 4 | |
| 2024-06-24 | 483 Safecor Health, LLCJun 24, 2024 · Woburn, Massachusetts | Woburn, Massachusetts | 3 | |
| 2024-04-16 | 483 Molecular MS Diagnostics, LLCApr 16, 2024 · Warwick, Rhode Island | Warwick, Rhode Island | 2 | |
| 2024-03-20 | 483 Homeocare LaboratoriesMar 20, 2024 · Yonkers, New York | Yonkers, New York | 12 | |
| 2024-01-25 | 483 Form 483 · FEI 3013722099Jan 25, 2024 · Burligton, Massachusetts | Burligton, Massachusetts | 1 | |
| 2023-12-01 | 483 TAYCA CORPORATIONDec 1, 2023 · Akaiwa, Japan | Akaiwa, Japan | 1 |
About this profile
What does Erik W. Koester inspect?
Erik W. Koester appears on 40 documents on file covering 32 sites, mostly in Massachusetts.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 211.67 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 Erik W. Koester is dated Jun 15, 2026.