McKenna Labs, LLC
FDA inspection history in Fullerton, California, 2020 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Fullerton, California.
- 2020The longest 483 on file: 5 observations over 3 pages at Fullerton, California.
- 2025One Form 483, at Fullerton, California.
Cited most
Across all McKenna Labs observations on file
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.194(a)(4)Laboratory records2
- 21 CFR 211.186(b)(9)Master production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
The complete McKenna Labs file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fullerton, California
Two Form 483s · 2020 to 2025 · 7 observations
Latest: Form 483, Feb 13, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-13 | 483 Form 483 | Fullerton, California | 2 | $99 |
| 2020-03-05 | 483 Form 483 | Fullerton, California | 5 | $99 |
Investigators on these documents
FEI number 3003449422 · most recent document Feb 13, 2025
About McKenna Labs, LLC
How many FDA Form 483s has McKenna Labs, LLC received?
FDA Intel has 2 Form 483s on file for McKenna Labs, LLC; the most recent is dated Feb 13, 2025.
When was McKenna Labs, LLC last inspected by FDA?
The most recent FDA inspection document on file for McKenna Labs, LLC is a Form 483 dated Feb 13, 2025, for the site in Fullerton, California.
What did FDA cite at McKenna Labs, LLC?
The regulations cited most in the observations on file for McKenna Labs, LLC are 21 CFR 211.188 (Batch production and control records), 2 times; 21 CFR 211.194(a)(4) (Laboratory records), 2 times; 21 CFR 211.186(b)(9) (Master production and control records), 1 time.