Nitto Avecia Pharma Services, Inc.
Form 483 issued January 24, 2020 · Irvine, California
- Inspection
- Jan 22 – Jan 24, 2020
- Observations
- 1
- Pages
- 3
- FEI number
- 3012971227
In short: On January 24, 2020, FDA issued a Form 483 with 1 observation to Nitto Avecia Pharma Services, Inc. in Irvine, California (FEI 3012971227) after an inspection that ran Jan 22 – Jan 24, 2020. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Questions about this 483
What did FDA find at Nitto Avecia Pharma Services, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Nitto Avecia Pharma Services, Inc. inspected by FDA?
The inspection ran Jan 22 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Nitto Avecia Pharma Services, 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.