Yusef Manufacturing Laboratories, LLC
Form 483 issued November 4, 2022 · Clearfield, Utah
- Inspection
- Oct 31 – Nov 4, 2022
- Investigators
- Alan P. Kurtzberg· Andrew Le· Lisa Shin
- Observations
- 12
- Pages
- 7
- FEI number
- 3004845420
In short: On November 4, 2022, FDA issued a Form 483 with 12 observations to Yusef Manufacturing Laboratories, LLC in Clearfield, Utah (FEI 3004845420) after an inspection that ran Oct 31 – Nov 4, 2022. The investigators were Alan P. Kurtzberg, Andrew Le and Lisa Shin. Most observations concern laboratory controls and materials; 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 laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The written stability testing…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Verification of the suitability of the testing methods is deficient in that they are not performed…
- 04
The calibration of instruments and apparatus is not…
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 firmYusef Manufacturing Laboratories, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yusef Manufacturing Laboratories, LLC?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, materials and production. 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 Yusef Manufacturing Laboratories, LLC?
Alan P. Kurtzberg, Andrew Le and Lisa Shin are named on this Form 483, for the inspection of Oct 31 – Nov 4, 2022. Each investigator has a profile showing what they cite most.
When was Yusef Manufacturing Laboratories, LLC inspected by FDA?
The inspection ran Oct 31 – Nov 4, 2022, and the Form 483 is dated November 4, 2022.
How do I get the full Form 483 for Yusef Manufacturing Laboratories, 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.