Kenlor Industries, Inc.
Form 483 issued May 3, 2019 · Santa Ana, California
- Inspection
- Apr 29 – May 3, 2019
- Investigator
- Janet Pulver
- Observations
- 3
- Pages
- 8
- FEI number
- 2027370
In short: On May 3, 2019, FDA issued a Form 483 with 3 observations to Kenlor Industries, Inc. in Santa Ana, California (FEI 2027370) after an inspection that ran Apr 29 – May 3, 2019. The investigator was Janet Pulver. Most observations concern records & documents and design controls.
At a glance
2 of 3 observations on this 483 concern records & documents.
What FDA observed
Preview: the opening words of each observation- 01
A device master record has…
- 02
Procedures for device history records have…
- 03
Procedures for design control…
This inspection in context
Janet Pulver
10 documents · 2014–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmKenlor Industries, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kenlor Industries, Inc.?
FDA listed 3 observations on this Form 483, mostly about records & documents and design controls. The opening words of each observation are shown on this page.
Who inspected Kenlor Industries, Inc.?
Janet Pulver is named on this Form 483, for the inspection of Apr 29 – May 3, 2019. Each investigator has a profile showing what they cite most.
When was Kenlor Industries, Inc. inspected by FDA?
The inspection ran Apr 29 – May 3, 2019, and the Form 483 is dated May 3, 2019.
How do I get the full Form 483 for Kenlor Industries, 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.