Yusef Manufacturing Laboratories, LLC
Form 483 issued May 26, 2016 · Clearfield, Utah
- Inspection
- May 23 – May 26, 2016
- Investigators
- Tenzin Jangchup· Zachary L. Stamm
- Observations
- 16
- Pages
- 7
- FEI number
- 3004845420
In short: On May 26, 2016, FDA issued a Form 483 with 16 observations to Yusef Manufacturing Laboratories, LLC in Clearfield, Utah (FEI 3004845420) after an inspection that ran May 23 – May 26, 2016. The investigators were Tenzin Jangchup and Zachary L. Stamm. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Tenzin Jangchup
14 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yusef Manufacturing Laboratories, LLC?
FDA listed 16 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Yusef Manufacturing Laboratories, LLC?
Tenzin Jangchup and Zachary L. Stamm are named on this Form 483, for the inspection of May 23 – May 26, 2016. Each investigator has a profile showing what they cite most.
When was Yusef Manufacturing Laboratories, LLC inspected by FDA?
The inspection ran May 23 – May 26, 2016, and the Form 483 is dated May 26, 2016.
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.