McKenna Labs, LLC
Form 483 issued February 13, 2025 · Fullerton, California
- Inspection
- Feb 10 – Feb 13, 2025
- Investigator
- Tiara M. Brown
- Observations
- 2
- Pages
- 3
- FEI number
- 3003449422
In short: On February 13, 2025, FDA issued a Form 483 with 2 observations to McKenna Labs, LLC in Fullerton, California (FEI 3003449422) after an inspection that ran Feb 10 – Feb 13, 2025. The investigator was Tiara M. Brown. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (1×) · 211.194(a)(5) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Laboratory records do not include a record of all calculations performed in…
This inspection in context
Tiara M. Brown
6 documents · 2022–2025
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmMcKenna Labs, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McKenna Labs, LLC?
FDA listed 2 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected McKenna Labs, LLC?
Tiara M. Brown is named on this Form 483, for the inspection of Feb 10 – Feb 13, 2025. Each investigator has a profile showing what they cite most.
When was McKenna Labs, LLC inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2025, and the Form 483 is dated February 13, 2025.
How do I get the full Form 483 for McKenna Labs, LLC?
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.