Kenlor Industries, Inc.
Form 483 issued September 21, 2020 · Santa Ana, California
- Inspection
- Sep 15 – Sep 21, 2020
- Investigator
- Creighton T. Tuzon
- Observations
- 5
- Pages
- 5
- FEI number
- 2027370
In short: On September 21, 2020, FDA issued a Form 483 with 5 observations to Kenlor Industries, Inc. in Santa Ana, California (FEI 2027370) after an inspection that ran Sep 15 – Sep 21, 2020. The investigator was Creighton T. Tuzon. Most observations concern production & process controls and management controls.
At a glance
Production & process controls and management controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
- 02
Procedures to ensure equipment is routinely calibrated have…
- 03
Records of changes to documents…
- 04
The dates of quality audits…
This inspection in context
Creighton T. Tuzon
6 documents · 2020–2025
Cites 1271.47 (what procedures must i establish and maintain?) 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 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kenlor Industries, Inc.?
FDA listed 5 observations on this Form 483, mostly about production & process controls, management controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Kenlor Industries, Inc.?
Creighton T. Tuzon is named on this Form 483, for the inspection of Sep 15 – Sep 21, 2020. Each investigator has a profile showing what they cite most.
When was Kenlor Industries, Inc. inspected by FDA?
The inspection ran Sep 15 – Sep 21, 2020, and the Form 483 is dated September 21, 2020.
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.