Yusef Manufacturing Laboratories, LLC
Form 483 issued September 13, 2019 · Clearfield, Utah
- Investigator
- Nayan J. Patel
- Observations
- 3
- Pages
- 2
- FEI number
- 3004845420
In short: On September 13, 2019, FDA issued a Form 483 with 3 observations to Yusef Manufacturing Laboratories, LLC in Clearfield, Utah (FEI 3004845420). The investigator was Nayan J. Patel. Most observations concern laboratory controls and quality system.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
There is no written testing program designed to assess the stability…
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 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 211.165(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 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Yusef Manufacturing Laboratories, LLC?
Nayan J. Patel is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Yusef Manufacturing Laboratories, LLC inspected by FDA?
This Form 483 is dated September 13, 2019.
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.