Koko, LLC
Form 483 issued January 25, 2021 · Longmont, Colorado
- Inspection
- Jan 5 – Jan 25, 2021
- Investigator
- Christine I. Shaw
- Observations
- 9
- Pages
- 10
- FEI number
- 1000117266
In short: On January 25, 2021, FDA issued a Form 483 with 9 observations to Koko, LLC in Longmont, Colorado (FEI 1000117266) after an inspection that ran Jan 5 – Jan 25, 2021. The investigator was Christine I. Shaw. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and design controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Software used as part of production has not been validated for its intended use according…
- 03
Procedures for design change have…
- 04
Procedures for changes to a specification, method, process and procedure have…
This inspection in context
Christine I. Shaw
8 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.
The firmKoko, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Koko, LLC?
FDA listed 9 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Koko, LLC?
Christine I. Shaw is named on this Form 483, for the inspection of Jan 5 – Jan 25, 2021. Each investigator has a profile showing what they cite most.
When was Koko, LLC inspected by FDA?
The inspection ran Jan 5 – Jan 25, 2021, and the Form 483 is dated January 25, 2021.
How do I get the full Form 483 for Koko, 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.