Xlear Inc
Form 483 issued March 18, 2022 · American Fork, Utah
- Inspection
- Mar 14 – Mar 18, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 9
- Pages
- 7
- FEI number
- 3010166224
In short: On March 18, 2022, FDA issued a Form 483 with 9 observations to Xlear Inc in American Fork, Utah (FEI 3010166224) after an inspection that ran Mar 14 – Mar 18, 2022. The investigator was Alan P. Kurtzberg. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
The number of containers to be sampled is not…
- 02
Containers from which samples have been taken are not marked to show that samples have…
- 03
An adequate number of batches of each drug product are not tested to determine…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmXlear Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xlear Inc?
FDA listed 9 observations on this Form 483, mostly about materials, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Xlear Inc?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Mar 14 – Mar 18, 2022. Each investigator has a profile showing what they cite most.
When was Xlear Inc inspected by FDA?
The inspection ran Mar 14 – Mar 18, 2022, and the Form 483 is dated March 18, 2022.
How do I get the full Form 483 for Xlear 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.