Advantage Metalwork and Finishing, LLC
Form 483 issued February 29, 2024 · Rochester, New York
- Inspection
- Feb 26 – Feb 29, 2024
- Investigator
- Matthew D. Schnittker
- Observations
- 2
- Pages
- 6
- FEI number
- 3027558152
In short: On February 29, 2024, FDA issued a Form 483 with 2 observations to Advantage Metalwork and Finishing, LLC in Rochester, New York (FEI 3027558152) after an inspection that ran Feb 26 – Feb 29, 2024. The investigator was Matthew D. Schnittker. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.90(a) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmAdvantage Metalwork and Finishing, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advantage Metalwork and Finishing, LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Advantage Metalwork and Finishing, LLC?
Matthew D. Schnittker is named on this Form 483, for the inspection of Feb 26 – Feb 29, 2024. Each investigator has a profile showing what they cite most.
When was Advantage Metalwork and Finishing, LLC inspected by FDA?
The inspection ran Feb 26 – Feb 29, 2024, and the Form 483 is dated February 29, 2024.
How do I get the full Form 483 for Advantage Metalwork and Finishing, LLC?
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