Wilsey Tool Company Inc
Form 483 issued March 28, 2019 · Quakertown, Pennsylvania
- Inspection
- Mar 27 – Mar 28, 2019
- Investigator
- Brian S. Keefer
- Observations
- 2
- Pages
- 4
- FEI number
- 3001642380
In short: On March 28, 2019, FDA issued a Form 483 with 2 observations to Wilsey Tool Company Inc in Quakertown, Pennsylvania (FEI 3001642380) after an inspection that ran Mar 27 – Mar 28, 2019. The investigator was Brian S. Keefer. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75(a) (1×) · 820.72(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Equipment calibrations and maintenance activities…
This inspection in context
Brian S. Keefer
6 documents · 2011–2019
Cites 118.10(a)(3)(iv) (recordkeeping requirements for the salmonella enteritidis (se) prevention plan) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmWilsey Tool Company Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wilsey Tool Company Inc?
FDA listed 2 observations on this Form 483, mostly about 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 Wilsey Tool Company Inc?
Brian S. Keefer is named on this Form 483, for the inspection of Mar 27 – Mar 28, 2019. Each investigator has a profile showing what they cite most.
When was Wilsey Tool Company Inc inspected by FDA?
The inspection ran Mar 27 – Mar 28, 2019, and the Form 483 is dated March 28, 2019.
How do I get the full Form 483 for Wilsey Tool Company Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.