FHC, Inc
Form 483 issued November 26, 2024 · Greenville, Pennsylvania
- Inspection
- Nov 18 – Nov 26, 2024
- Investigator
- Dennis R. Hock
- Observations
- 4
- Pages
- 10
- FEI number
- 3005161223
In short: On November 26, 2024, FDA issued a Form 483 with 4 observations to FHC, Inc in Greenville, Pennsylvania (FEI 3005161223) after an inspection that ran Nov 18 – Nov 26, 2024. The investigator was Dennis R. Hock. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 3 of 4 observations.
Most cited: 21 CFR 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Design validation did not ensure the device conforms to defined user…
- 02
Production processes were not developed, controlled and monitored to ensure that a device…
- 03
Risk analysis is…
- 0421 CFR 820.20(b)21 CFR 820
The organizational structure has not been adequately established and maintained to ensure that devices are designed…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmFHC, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FHC, Inc?
FDA listed 4 observations on this Form 483, mostly about design controls, production & process controls and management controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected FHC, Inc?
Dennis R. Hock is named on this Form 483, for the inspection of Nov 18 – Nov 26, 2024. Each investigator has a profile showing what they cite most.
When was FHC, Inc inspected by FDA?
The inspection ran Nov 18 – Nov 26, 2024, and the Form 483 is dated November 26, 2024.
How do I get the full Form 483 for FHC, Inc?
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