Scientific Protein Laboratories
FDA inspection history in Waunakee, Wisconsin, 2009 to 2025
- 4
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2009: two Form 483s; 2010: one Form 483; 2011: one warning letter; 2020: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–11Three Form 483s and one warning letter, at Waunakee, Wisconsin.
- 2009The longest 483 on file: 29 observations over 8 pages at Waunakee, Wisconsin.
- 2020One Form 483, at Waunakee, Wisconsin.
- 2025One warning letter, at Waunakee, Wisconsin.
Cited most
Across all Scientific Protein Laboratories observations on file
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
The complete Scientific Protein Laboratories file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Waunakee, Wisconsin
Four Form 483s and two warning letters · 2009 to 2025 · 42 observations
Latest: Warning letter, Oct 10, 2025 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-10-10 | Warning letter Warning letter | Waunakee, Wisconsin | — | $99 |
| 2020-01-10 | 483 Form 483 | Waunakee, Wisconsin | 3 | $99 |
| 2011-01-20 | Warning letter Warning letter | Waunakee, Wisconsin | — | $99 |
| 2010-09-03 | 483 Form 483 | Waunakee, Wisconsin | 4 | $99 |
| 2009-12-15 | 483 Form 483 | Waunakee, Wisconsin | 6 | $99 |
| 2009-05-08 | 483 Form 483 | Waunakee, Wisconsin | 29 | $99 |
Investigators on these documents
Alan M. Roberts (1)Bruce Huang (1)Justin A. Boyd (1)Lori A. Joyner (1)Marie A. Fadden (1)Michael J. Bicker (1)Sandra A. Hughes (1)Sandra A. Jukuri (1)Sharon K. Thoma (1)William Heller (1)
FEI number 2111173 · most recent document Oct 10, 2025
About Scientific Protein Laboratories
How many FDA Form 483s has Scientific Protein Laboratories received?
FDA Intel has 4 Form 483s on file for Scientific Protein Laboratories; the most recent is dated Jan 10, 2020.
When was Scientific Protein Laboratories last inspected by FDA?
The most recent FDA inspection document on file for Scientific Protein Laboratories is a Form 483 dated Jan 10, 2020, for the site in Waunakee, Wisconsin.
What did FDA cite at Scientific Protein Laboratories?
The regulations cited most in the observations on file for Scientific Protein Laboratories are 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times.
Has Scientific Protein Laboratories received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Scientific Protein Laboratories; the most recent is dated Oct 10, 2025.