Kelyniam Global, Inc.
Form 483 issued August 15, 2019 · Collinsville, Connecticut
- Inspection
- Jul 24 – Aug 15, 2019
- Investigator
- Jeffrey J. Thibodeau
- Observations
- 1
- Pages
- 5
- FEI number
- 3009424796
In short: On August 15, 2019, FDA issued a Form 483 with 1 observation to Kelyniam Global, Inc. in Collinsville, Connecticut (FEI 3009424796) after an inspection that ran Jul 24 – Aug 15, 2019. The investigator was Jeffrey J. Thibodeau. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions…
This inspection in context
Jeffrey J. Thibodeau
7 documents · 2015–2024
Cites 820.70(b) (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
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 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kelyniam Global, Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. 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 Kelyniam Global, Inc.?
Jeffrey J. Thibodeau is named on this Form 483, for the inspection of Jul 24 – Aug 15, 2019. Each investigator has a profile showing what they cite most.
When was Kelyniam Global, Inc. inspected by FDA?
The inspection ran Jul 24 – Aug 15, 2019, and the Form 483 is dated August 15, 2019.
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.