Nitto Denko Avecia Inc.
Form 483 issued February 8, 2023 · Milford, Massachusetts
- Inspection
- Jan 19 – Feb 8, 2023
- Investigator
- Erik W. Koester
- Observations
- 5
- Pages
- 6
- FEI number
- 3000215431
In short: On February 8, 2023, FDA issued a Form 483 with 5 observations to Nitto Denko Avecia Inc. in Milford, Massachusetts (FEI 3000215431) after an inspection that ran Jan 19 – Feb 8, 2023. The investigator was Erik W. Koester. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm’s Quality Unit failed to adequately investigate Deviation# DEVN-MA-000388. The aforementioned deviation was initiated on…
- 02
Retention of batch production and control records are deficient. The firm’s storage or security of completed…
- 03
The firm has failed to follow their stability program procedure: SOP-000341, in that stability testing is…
- 04
The firm’s Quality Unit has failed to review and approve the following Quality related reports within…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNitto Denko Avecia Inc. history
The site's inspection history, in date order.
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 Denko Avecia Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Nitto Denko Avecia Inc.?
Erik W. Koester is named on this Form 483, for the inspection of Jan 19 – Feb 8, 2023. Each investigator has a profile showing what they cite most.
When was Nitto Denko Avecia Inc. inspected by FDA?
The inspection ran Jan 19 – Feb 8, 2023, and the Form 483 is dated February 8, 2023.
How do I get the full Form 483 for Nitto Denko Avecia Inc.?
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