Calmare Therapeutics, Inc
FDA inspection history in Shelton, Connecticut, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Shelton, Connecticut.
Cited most
Across all Calmare Therapeutics observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
The complete Calmare Therapeutics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Shelton, Connecticut
One Form 483 · 2024 · 6 observations
Latest: Form 483, May 22, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-22 | 483 Form 483 | Shelton, Connecticut | 6 | $99 |
Investigators on these documents
FEI number 3006435903 · most recent document May 22, 2024
About Calmare Therapeutics, Inc
How many FDA Form 483s has Calmare Therapeutics, Inc received?
FDA Intel has 1 Form 483 on file for Calmare Therapeutics, Inc; the most recent is dated May 22, 2024.
When was Calmare Therapeutics, Inc last inspected by FDA?
The most recent FDA inspection document on file for Calmare Therapeutics, Inc is a Form 483 dated May 22, 2024, for the site in Shelton, Connecticut.
What did FDA cite at Calmare Therapeutics, Inc?
The regulations cited most in the observations on file for Calmare Therapeutics, Inc are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time.