Life Science Outsourcing, Inc
Form 483 issued November 12, 2020 · Brea, California
- Inspection
- Nov 6 – Nov 12, 2020
- Investigator
- Truong X. Nguyen
- Observations
- 3
- Pages
- 3
- FEI number
- 3001236549
In short: On November 12, 2020, FDA issued a Form 483 with 3 observations to Life Science Outsourcing, Inc in Brea, California (FEI 3001236549) after an inspection that ran Nov 6 – Nov 12, 2020. The investigator was Truong X. Nguyen. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
- 03
The master production and control records for each batch size of drug product are not prepared…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmLife Science Outsourcing, Inc history
The site's inspection history, in date order.
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 Life Science Outsourcing, Inc?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Life Science Outsourcing, Inc?
Truong X. Nguyen is named on this Form 483, for the inspection of Nov 6 – Nov 12, 2020. Each investigator has a profile showing what they cite most.
When was Life Science Outsourcing, Inc inspected by FDA?
The inspection ran Nov 6 – Nov 12, 2020, and the Form 483 is dated November 12, 2020.
How do I get the full Form 483 for Life Science Outsourcing, 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.