Wilson-Hurd Mfg. Co., Inc
Form 483 issued February 18, 2015 · Berlin, Wisconsin
- Inspection
- Jan 27 – Feb 18, 2015
- Investigator
- Corey K. Reno
- Observations
- 7
- Pages
- 5
- FEI number
- 3007693661
In short: On February 18, 2015, FDA issued a Form 483 with 7 observations to Wilson-Hurd Mfg. Co., Inc in Berlin, Wisconsin (FEI 3007693661) after an inspection that ran Jan 27 – Feb 18, 2015. The investigator was Corey K. Reno. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
Production & process controls and capa account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
- 02
There is no documentation of the review and evaluation of a process and revalidation of a…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Document control procedures have…
This inspection in context
Corey K. Reno
2 documents · 2014–2015
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Wisconsin.
The firmWilson-Hurd Mfg. Co., Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wilson-Hurd Mfg. Co., Inc?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Wilson-Hurd Mfg. Co., Inc?
Corey K. Reno is named on this Form 483, for the inspection of Jan 27 – Feb 18, 2015. Each investigator has a profile showing what they cite most.
When was Wilson-Hurd Mfg. Co., Inc inspected by FDA?
The inspection ran Jan 27 – Feb 18, 2015, and the Form 483 is dated February 18, 2015.
How do I get the full Form 483 for Wilson-Hurd Mfg. Co., Inc?
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