Front Range Laboratories Inc
Form 483 issued March 20, 2020 · Loveland, Colorado
- Inspection
- Mar 16 – Mar 20, 2020
- Investigators
- Nayan J. Patel· Walden H. Lee
- Observations
- 3
- Pages
- 3
- FEI number
- 3003240654
In short: On March 20, 2020, FDA issued a Form 483 with 3 observations to Front Range Laboratories Inc in Loveland, Colorado (FEI 3003240654) after an inspection that ran Mar 16 – Mar 20, 2020. The investigators were Nayan J. Patel and Walden H. Lee. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, specificity and reproducibility of test methods…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Input to and output from records or data are…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
The firmFront Range Laboratories Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Front Range Laboratories Inc?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Front Range Laboratories Inc?
Nayan J. Patel and Walden H. Lee are named on this Form 483, for the inspection of Mar 16 – Mar 20, 2020. Each investigator has a profile showing what they cite most.
When was Front Range Laboratories Inc inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2020, and the Form 483 is dated March 20, 2020.
How do I get the full Form 483 for Front Range Laboratories Inc?
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.