Scientific Protein Laboratories
Form 483 issued December 15, 2009 · Waunakee, Wisconsin
- Inspection
- Nov 30 – Dec 15, 2009
- Investigators
- Lori A. Joyner· Michael J. Bicker· Sandra A. Jukuri
- Observations
- 6
- Pages
- 2
- FEI number
- 2111173
In short: On December 15, 2009, FDA issued a Form 483 with 6 observations to Scientific Protein Laboratories in Waunakee, Wisconsin (FEI 2111173) after an inspection that ran Nov 30 – Dec 15, 2009. The investigators were Lori A. Joyner, Michael J. Bicker and Sandra A. Jukuri. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.100 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all deviations from normal production are documented and explained in the…
- 02
Not all materials (ingredients, starting materials) are stored in a manner to prevent…
- 03
Process validation efforts are not always suitable in that critical parameters / attributes are sometimes missed…
- 04
Written cleaning procedures for equipment including dryers, tanks, blenders and rooms include a description of the…
This inspection in context
Lori A. Joyner
1 document · 2009
Cites 211.100 (written procedures; deviations) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Scientific Protein Laboratories?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. 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?
Lori A. Joyner, Michael J. Bicker and Sandra A. Jukuri are named on this Form 483, for the inspection of Nov 30 – Dec 15, 2009. Each investigator has a profile showing what they cite most.
When was Scientific Protein Laboratories inspected by FDA?
The inspection ran Nov 30 – Dec 15, 2009, and the Form 483 is dated December 15, 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.