Koko, LLC
FDA inspection history in Longmont, Colorado, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Longmont, Colorado.
Cited most
Across all Koko observations on file
- 21 CFR 820.30(g)Design controls2
- 21 CFR 820.70(b)Production and process controls2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.181Device master record1
- 21 CFR 820.198(a)Complaint files1
The complete Koko file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Longmont, Colorado
One Form 483 · 2021 · 9 observations
Latest: Form 483, Jan 25, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-01-25 | 483 Form 483 | Longmont, Colorado | 9 | $99 |
Investigators on these documents
FEI number 1000117266 · most recent document Jan 25, 2021
About Koko, LLC
How many FDA Form 483s has Koko, LLC received?
FDA Intel has 1 Form 483 on file for Koko, LLC; the most recent is dated Jan 25, 2021.
When was Koko, LLC last inspected by FDA?
The most recent FDA inspection document on file for Koko, LLC is a Form 483 dated Jan 25, 2021, for the site in Longmont, Colorado.
What did FDA cite at Koko, LLC?
The regulations cited most in the observations on file for Koko, LLC are 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 820.70(b) (Production and process controls), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.