Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
FDA inspection history in Peoria, Illinois, 2015 to 2018
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s and one warning letter, at Peoria, Illinois.
- 2015The longest 483 on file: 15 observations over 8 pages at Peoria, Illinois.
Cited most
Across all Kalman Health & Wellness, Inc. dba Essential Wellness Pharma observations on file
- 21 CFR 211.42(c)Design and construction features3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.165(a)Testing and release for distribution1
The complete Kalman Health & Wellness, Inc. dba Essential Wellness Pharma file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Peoria, Illinois
Two Form 483s and one warning letter · 2015 to 2018 · 17 observations
Latest: Form 483, Jun 27, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-06-27 | 483 Form 483 | Peoria, Illinois | 2 | $99 |
| 2016-07-22 | Warning letter Warning letter | Peoria, Illinois | — | $99 |
| 2015-07-21 | 483 Form 483 | Peoria, Illinois | 15 | $99 |
Investigators on these documents
Brian D. Nicholson (1)Gary C. Pecic (1)Lisa T. Michel (1)Russell K. Riley (1)
FEI number 3011581046 · most recent document Jun 27, 2018
About Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
How many FDA Form 483s has Kalman Health & Wellness, Inc. dba Essential Wellness Pharma received?
FDA Intel has 2 Form 483s on file for Kalman Health & Wellness, Inc. dba Essential Wellness Pharma; the most recent is dated Jun 27, 2018.
When was Kalman Health & Wellness, Inc. dba Essential Wellness Pharma last inspected by FDA?
The most recent FDA inspection document on file for Kalman Health & Wellness, Inc. dba Essential Wellness Pharma is a Form 483 dated Jun 27, 2018, for the site in Peoria, Illinois.
What did FDA cite at Kalman Health & Wellness, Inc. dba Essential Wellness Pharma?
The regulations cited most in the observations on file for Kalman Health & Wellness, Inc. dba Essential Wellness Pharma are 21 CFR 211.42(c) (Design and construction features), 3 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has Kalman Health & Wellness, Inc. dba Essential Wellness Pharma received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Kalman Health & Wellness, Inc. dba Essential Wellness Pharma; the most recent is dated Jul 22, 2016.