SV Labs Prescott Corporation
Form 483 issued September 28, 2018 · Prescott, Wisconsin
- Inspection
- Sep 6 – Sep 28, 2018
- Investigators
- James K. Ireland· Ross J. Grigsby· Scott A. Golladay
- Observations
- 15
- Pages
- 10
- FEI number
- 2130687
In short: On September 28, 2018, FDA issued a Form 483 with 15 observations to SV Labs Prescott Corporation in Prescott, Wisconsin (FEI 2130687) after an inspection that ran Sep 6 – Sep 28, 2018. The investigators were James K. Ireland, Ross J. Grigsby and Scott A. Golladay. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Laboratory controls and quality system account for 10 of 15 observations.
Most cited: 21 CFR 211.68(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
The quality control unit lacks authority to review production records to assure that no errors have…
- 04
Written procedures are not established for evaluations conducted at least (b) (4) _ to review records…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmSV Labs Prescott Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SV Labs Prescott Corporation?
FDA listed 15 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected SV Labs Prescott Corporation?
James K. Ireland, Ross J. Grigsby and Scott A. Golladay are named on this Form 483, for the inspection of Sep 6 – Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was SV Labs Prescott Corporation inspected by FDA?
The inspection ran Sep 6 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.
How do I get the full Form 483 for SV Labs Prescott Corporation?
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.