Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Form 483 issued July 21, 2015 · Peoria, Illinois
- Inspection
- Jun 2 – Jul 21, 2015
- Investigators
- Gary C. Pecic· Lisa T. Michel· Russell K. Riley
- Observations
- 15
- Pages
- 8
- FEI number
- 3011581046
In short: On July 21, 2015, FDA issued a Form 483 with 15 observations to Kalman Health & Wellness, Inc. dba Essential Wellness Pharma in Peoria, Illinois (FEI 3011581046) after an inspection that ran Jun 2 – Jul 21, 2015. The investigators were Gary C. Pecic, Lisa T. Michel and Russell K. Riley. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 9 of 15 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
The separate or defined areas necessary to prevent contamination…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Gary C. Pecic
7 documents · 2015–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Washington.
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 211.113(b)
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 15 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Kalman Health & Wellness, Inc. dba Essential Wellness Pharma?
Gary C. Pecic, Lisa T. Michel and Russell K. Riley are named on this Form 483, for the inspection of Jun 2 – Jul 21, 2015. 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 2 – Jul 21, 2015, and the Form 483 is dated July 21, 2015.
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.