Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Form 483 issued June 27, 2018 · Peoria, Illinois
- Inspection
- Jun 19 – Jun 27, 2018
- Investigator
- Brian D. Nicholson
- Observations
- 2
- Pages
- 1
- FEI number
- 3011581046
In short: On June 27, 2018, FDA issued a Form 483 with 2 observations to Kalman Health & Wellness, Inc. dba Essential Wellness Pharma in Peoria, Illinois (FEI 3011581046) after an inspection that ran Jun 19 – Jun 27, 2018. The investigator was Brian D. Nicholson. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for cleaning and sanitization of common, nondedicated equipment used to make drug products have not…
- 02
Your firm is currently using (b)(4) water in (b)(4) plastic containers to…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmKalman Health & Wellness, Inc. dba Essential Wellness Pharma history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kalman Health & Wellness, Inc. dba Essential Wellness Pharma?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Kalman Health & Wellness, Inc. dba Essential Wellness Pharma?
Brian D. Nicholson is named on this Form 483, for the inspection of Jun 19 – Jun 27, 2018. Each investigator has a profile showing what they cite most.
When was Kalman Health & Wellness, Inc. dba Essential Wellness Pharma inspected by FDA?
The inspection ran Jun 19 – Jun 27, 2018, and the Form 483 is dated June 27, 2018.
How do I get the full Form 483 for Kalman Health & Wellness, Inc. dba Essential Wellness Pharma?
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.