Scientific Protein Laboratories
Form 483 issued January 10, 2020 · Waunakee, Wisconsin
- Inspection
- Jan 6 – Jan 10, 2020
- Investigators
- Alan M. Roberts· Bruce Huang· William Heller
- Observations
- 3
- Pages
- 3
- FEI number
- 2111173
In short: On January 10, 2020, FDA issued a Form 483 with 3 observations to Scientific Protein Laboratories in Waunakee, Wisconsin (FEI 2111173) after an inspection that ran Jan 6 – Jan 10, 2020. The investigators were Alan M. Roberts, Bruce Huang and William Heller. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 3 observations.
Most cited: 21 CFR 211.160 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
scientific etion ‘befite Tetesting…
- 02
The procedures applicable,to: the quality control gaihare not in writing or, fully…
- 03
Written production and process control procedures : are not followed in the execution of production and…
This inspection in context
Alan M. Roberts
4 documents · 2019–2021
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Illinois.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Scientific Protein Laboratories?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Scientific Protein Laboratories?
Alan M. Roberts, Bruce Huang and William Heller are named on this Form 483, for the inspection of Jan 6 – Jan 10, 2020. Each investigator has a profile showing what they cite most.
When was Scientific Protein Laboratories inspected by FDA?
The inspection ran Jan 6 – Jan 10, 2020, and the Form 483 is dated January 10, 2020.
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.