Nitto Avecia Pharma Services, Inc.
Form 483 issued September 22, 2023 · Irvine, California
- Inspection
- Sep 18 – Sep 22, 2023
- Investigator
- Wenzheng Zhang
- Observations
- 2
- Pages
- 2
- FEI number
- 3012971227
In short: On September 22, 2023, FDA issued a Form 483 with 2 observations to Nitto Avecia Pharma Services, Inc. in Irvine, California (FEI 3012971227) after an inspection that ran Sep 18 – Sep 22, 2023. The investigator was Wenzheng Zhang. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to…
- 02
The proposal for GMP relevant changes was not drafted, reviewed and approved by your firm's appropriate…
This inspection in context
Wenzheng Zhang
8 documents · 2019–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmNitto Avecia Pharma Services, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nitto Avecia Pharma Services, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Nitto Avecia Pharma Services, Inc.?
Wenzheng Zhang is named on this Form 483, for the inspection of Sep 18 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Nitto Avecia Pharma Services, Inc. inspected by FDA?
The inspection ran Sep 18 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Nitto Avecia Pharma Services, Inc.?
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