McKenna Labs, LLC
Form 483 issued March 5, 2020 · Fullerton, California
- Inspection
- Mar 2 – Mar 5, 2020
- Investigator
- Liming Zhang
- Observations
- 5
- Pages
- 3
- FEI number
- 3003449422
In short: On March 5, 2020, FDA issued a Form 483 with 5 observations to McKenna Labs, LLC in Fullerton, California (FEI 3003449422) after an inspection that ran Mar 2 – Mar 5, 2020. The investigator was Liming Zhang. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include a complete record of all data secured in the course of…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training and experience…
- 04
Master production and control records lack complete…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) 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 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McKenna Labs, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected McKenna Labs, LLC?
Liming Zhang is named on this Form 483, for the inspection of Mar 2 – Mar 5, 2020. Each investigator has a profile showing what they cite most.
When was McKenna Labs, LLC inspected by FDA?
The inspection ran Mar 2 – Mar 5, 2020, and the Form 483 is dated March 5, 2020.
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.