Pace Analytical Life Sciences, LLC
Form 483 issued May 4, 2015 · Oakdale, Minnesota
- Inspection
- Apr 23 – May 4, 2015
- Investigator
- April L. Young
- Observations
- 1
- Pages
- 2
- FEI number
- 3001452367
In short: On May 4, 2015, FDA issued a Form 483 with 1 observation to Pace Analytical Life Sciences, LLC in Oakdale, Minnesota (FEI 3001452367) after an inspection that ran Apr 23 – May 4, 2015. The investigator was April L. Young. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
April L. Young
5 documents · 2014–2015
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Minnesota.
The firmPace Analytical Life Sciences, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pace Analytical Life Sciences, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Pace Analytical Life Sciences, LLC?
April L. Young is named on this Form 483, for the inspection of Apr 23 – May 4, 2015. Each investigator has a profile showing what they cite most.
When was Pace Analytical Life Sciences, LLC inspected by FDA?
The inspection ran Apr 23 – May 4, 2015, and the Form 483 is dated May 4, 2015.
How do I get the full Form 483 for Pace Analytical Life Sciences, LLC?
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.