Bioduro LLC
Form 483 issued March 3, 2017 · Irvine, California
- Inspection
- Feb 21 – Mar 3, 2017
- Investigator
- Liming Zhang
- Observations
- 4
- Pages
- 3
- FEI number
- 3004492248
In short: On March 3, 2017, FDA issued a Form 483 with 4 observations to Bioduro LLC in Irvine, California (FEI 3004492248) after an inspection that ran Feb 21 – Mar 3, 2017. The investigator was Liming Zhang. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
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 test procedures designed to…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures describing the warehousing of drug…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmBioduro LLC history
All 3 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 Bioduro LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Bioduro LLC?
Liming Zhang is named on this Form 483, for the inspection of Feb 21 – Mar 3, 2017. Each investigator has a profile showing what they cite most.
When was Bioduro LLC inspected by FDA?
The inspection ran Feb 21 – Mar 3, 2017, and the Form 483 is dated March 3, 2017.
How do I get the full Form 483 for Bioduro 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.