Howmedica Osteonics Corp
Form 483 issued December 1, 2023 · Mahwah, New Jersey
- Inspection
- Nov 15 – Dec 1, 2023
- Investigators
- Frank J. Marciniak· Matthew W. Kyle· Shirley S. Wen
- Observations
- 1
- Pages
- 2
- FEI number
- 3003070421
In short: On December 1, 2023, FDA issued a Form 483 with 1 observation to Howmedica Osteonics Corp in Mahwah, New Jersey (FEI 3003070421) after an inspection that ran Nov 15 – Dec 1, 2023. The investigators were Frank J. Marciniak, Matthew W. Kyle and Shirley S. Wen. Most observations concern management controls; the most-cited regulation is 21 CFR 820.25 (personnel).
At a glance
1 of 1 observations on this 483 concern management controls.
Most cited: 21 CFR 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for training and identifying training needs have…
This inspection in context
Frank J. Marciniak
7 documents · 2018–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmHowmedica Osteonics Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Howmedica Osteonics Corp?
FDA listed 1 observation on this Form 483, mostly about management controls. The most-cited regulation is 21 CFR 820.25 (personnel). The opening words of each observation are shown on this page.
Who inspected Howmedica Osteonics Corp?
Frank J. Marciniak, Matthew W. Kyle and Shirley S. Wen are named on this Form 483, for the inspection of Nov 15 – Dec 1, 2023. Each investigator has a profile showing what they cite most.
When was Howmedica Osteonics Corp inspected by FDA?
The inspection ran Nov 15 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
How do I get the full Form 483 for Howmedica Osteonics Corp?
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