Scientific Protein Laboratories
Form 483 issued September 3, 2010 · Waunakee, Wisconsin
- Inspection
- Jul 28 – Sep 3, 2010
- Investigators
- Justin A. Boyd· Sandra A. Hughes
- Observations
- 4
- Pages
- 3
- FEI number
- 2111173
In short: On September 3, 2010, FDA issued a Form 483 with 4 observations to Scientific Protein Laboratories in Waunakee, Wisconsin (FEI 2111173) after an inspection that ran Jul 28 – Sep 3, 2010. The investigators were Justin A. Boyd and Sandra A. Hughes. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 2 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture of API intennediates is not of appropriate design and has not…
- 02
You did not adequately investigate a complaint that affected product quality and did not extend the…
- 03
You did not adequately evaluate and qualify…
- 04
You did not adequately evaluate your…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.65
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Scientific Protein Laboratories?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Scientific Protein Laboratories?
Justin A. Boyd and Sandra A. Hughes are named on this Form 483, for the inspection of Jul 28 – Sep 3, 2010. Each investigator has a profile showing what they cite most.
When was Scientific Protein Laboratories inspected by FDA?
The inspection ran Jul 28 – Sep 3, 2010, and the Form 483 is dated September 3, 2010.
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.