Yusef Manufacturing Laboratories, LLC
Form 483 issued September 24, 2021 · Clearfield, Utah
- Inspection
- Sep 20 – Sep 24, 2021
- Investigators
- Kham Phommachanh· Rafeeq Habeeb
- Observations
- 30
- Pages
- 13
- FEI number
- 3004845420
In short: On September 24, 2021, FDA issued a Form 483 with 30 observations to Yusef Manufacturing Laboratories, LLC in Clearfield, Utah (FEI 3004845420) after an inspection that ran Sep 20 – Sep 24, 2021. The investigators were Kham Phommachanh and Rafeeq Habeeb. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 19 of 30 observations.
Most cited: 21 CFR 211.68(b) (3×) · 211.194(a)(1) (2×)
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
Laboratory records do not include a description of the sample received for testing, the source or…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
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 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yusef Manufacturing Laboratories, LLC?
FDA listed 30 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Yusef Manufacturing Laboratories, LLC?
Kham Phommachanh and Rafeeq Habeeb are named on this Form 483, for the inspection of Sep 20 – Sep 24, 2021. Each investigator has a profile showing what they cite most.
When was Yusef Manufacturing Laboratories, LLC inspected by FDA?
The inspection ran Sep 20 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.
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.