Calmare Therapeutics, Inc
Form 483 issued May 22, 2024 · Shelton, Connecticut
- Inspection
- May 21 – May 22, 2024
- Investigator
- Katarzyna Plona
- Observations
- 6
- Pages
- 3
- FEI number
- 3006435903
In short: On May 22, 2024, FDA issued a Form 483 with 6 observations to Calmare Therapeutics, Inc in Shelton, Connecticut (FEI 3006435903) after an inspection that ran May 21 – May 22, 2024. The investigator was Katarzyna Plona. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for quality audits…
- 03
Procedures for management review…
- 04
Written MDR procedures have not…
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 firmCalmare Therapeutics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Calmare Therapeutics, Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected Calmare Therapeutics, Inc?
Katarzyna Plona is named on this Form 483, for the inspection of May 21 – May 22, 2024. Each investigator has a profile showing what they cite most.
When was Calmare Therapeutics, Inc inspected by FDA?
The inspection ran May 21 – May 22, 2024, and the Form 483 is dated May 22, 2024.
How do I get the full Form 483 for Calmare Therapeutics, 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.