Oxarc, LLC
Form 483 issued August 23, 2019 · Coeur D Alene, Idaho
- Inspection
- Aug 22 – Aug 23, 2019
- Investigator
- Anita Narula
- Observations
- 2
- Pages
- 4
- FEI number
- 1000151065
In short: On August 23, 2019, FDA issued a Form 483 with 2 observations to Oxarc, LLC in Coeur D Alene, Idaho (FEI 1000151065) after an inspection that ran Aug 22 – Aug 23, 2019. The investigator was Anita Narula. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine calibration and inspection of automatic, mechanical and electronic equipment is not performed according to a…
- 02
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmOxarc, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxarc, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. 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 Oxarc, LLC?
Anita Narula is named on this Form 483, for the inspection of Aug 22 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Oxarc, LLC inspected by FDA?
The inspection ran Aug 22 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 483 for Oxarc, 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.