Kelyniam Global, Inc.
Form 483 issued August 23, 2024 · Collinsville, Connecticut
- Inspection
- Aug 14 – Aug 23, 2024
- Investigator
- Katarzyna Plona
- Observations
- 5
- Pages
- 7
- FEI number
- 3009424796
In short: On August 23, 2024, FDA issued a Form 483 with 5 observations to Kelyniam Global, Inc. in Collinsville, Connecticut (FEI 3009424796) after an inspection that ran Aug 14 – Aug 23, 2024. The investigator was Katarzyna Plona. Most observations concern production & process controls and management controls.
At a glance
Production & process controls and management controls account for 4 of 5 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
A device history record has…
- 03
Procediues to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procediues for training and identifying training needs have…
This inspection in context
Katarzyna Plona
2 documents · 2024
Cites 820.22 (quality audit) more than any other section. Most of their documents are for sites in Connecticut.
The firmKelyniam Global, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Kelyniam Global, Inc.?
FDA listed 5 observations on this Form 483, mostly about production & process controls, management controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Kelyniam Global, Inc.?
Katarzyna Plona is named on this Form 483, for the inspection of Aug 14 – Aug 23, 2024. Each investigator has a profile showing what they cite most.
When was Kelyniam Global, Inc. inspected by FDA?
The inspection ran Aug 14 – Aug 23, 2024, and the Form 483 is dated August 23, 2024.
How do I get the full Form 483 for Kelyniam Global, Inc.?
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.