LICO Industries, LLC
Form 483 issued July 8, 2021 · Mohave Valley, Arizona
- Inspection
- Jul 7 – Jul 8, 2021
- Investigator
- Nicholas L. Hunt
- Observations
- 4
- Pages
- 2
- FEI number
- 3003411169
In short: On July 8, 2021, FDA issued a Form 483 with 4 observations to LICO Industries, LLC in Mohave Valley, Arizona (FEI 3003411169) after an inspection that ran Jul 7 – Jul 8, 2021. The investigator was Nicholas L. Hunt. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Determinations of conformance to appropriate written specifications for acceptance are not made and…
- 02
Routine calibration of automatic and electronic equipment is not performed according to a written program designed…
- 03
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmLICO Industries, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LICO Industries, LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected LICO Industries, LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of Jul 7 – Jul 8, 2021. Each investigator has a profile showing what they cite most.
When was LICO Industries, LLC inspected by FDA?
The inspection ran Jul 7 – Jul 8, 2021, and the Form 483 is dated July 8, 2021.
How do I get the full Form 483 for LICO Industries, 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.