Arch Medical Solutions - Elkhart
Form 483 issued December 18, 2024 · Elkhart, Indiana
- Inspection
- Dec 16 – Dec 18, 2024
- Investigator
- Suyang Qin
- Observations
- 4
- Pages
- 7
- FEI number
- 3009923627
In short: On December 18, 2024, FDA issued a Form 483 with 4 observations to Arch Medical Solutions - Elkhart in Elkhart, Indiana (FEI 3009923627) after an inspection that ran Dec 16 – Dec 18, 2024. The investigator was Suyang Qin. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
CAPA and production & process controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been established to control product that does not…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
A validated process was not reviewed and evaluated when changes…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Suyang Qin
9 documents · 2015–2026
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmArch Medical Solutions - Elkhart 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 Arch Medical Solutions - Elkhart?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Arch Medical Solutions - Elkhart?
Suyang Qin is named on this Form 483, for the inspection of Dec 16 – Dec 18, 2024. Each investigator has a profile showing what they cite most.
When was Arch Medical Solutions - Elkhart inspected by FDA?
The inspection ran Dec 16 – Dec 18, 2024, and the Form 483 is dated December 18, 2024.
How do I get the full Form 483 for Arch Medical Solutions - Elkhart?
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