Scientific Protein Laboratories
Form 483 issued May 8, 2009 · Waunakee, Wisconsin
- Inspection
- Apr 27 – Jun 8, 2009
- Investigators
- Marie A. Fadden· Sharon K. Thoma
- Observations
- 29
- Pages
- 8
- FEI number
- 2111173
In short: On May 8, 2009, FDA issued a Form 483 with 29 observations to Scientific Protein Laboratories in Waunakee, Wisconsin (FEI 2111173) after an inspection that ran Apr 27 – Jun 8, 2009. The investigators were Marie A. Fadden and Sharon K. Thoma. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.165 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Process Validation of Pancreatin/Pancrelipase API, Pancreatic Enzyme Concentrate (PEC) 1208 and 1206…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Marie A. Fadden
8 documents · 2004–2015
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Wisconsin.
The firmScientific Protein Laboratories history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Scientific Protein Laboratories?
FDA listed 29 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Scientific Protein Laboratories?
Marie A. Fadden and Sharon K. Thoma are named on this Form 483, for the inspection of Apr 27 – Jun 8, 2009. Each investigator has a profile showing what they cite most.
When was Scientific Protein Laboratories inspected by FDA?
The inspection ran Apr 27 – Jun 8, 2009, and the Form 483 is dated May 8, 2009.
How do I get the full Form 483 for Scientific Protein Laboratories?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.