The Wellness Pharmacy, LLC
Form 483 issued March 12, 2015 · Winchester, California
- Inspection
- Mar 9 – Mar 12, 2015
- Investigator
- Matthew B. Casale
- Observations
- 4
- Pages
- 4
- FEI number
- 3011402879
In short: On March 12, 2015, FDA issued a Form 483 with 4 observations to The Wellness Pharmacy, LLC in Winchester, California (FEI 3011402879) after an inspection that ran Mar 9 – Mar 12, 2015. The investigator was Matthew B. Casale. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
The control systems necessary to prevent contamination…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmThe Wellness Pharmacy, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Wellness Pharmacy, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected The Wellness Pharmacy, LLC?
Matthew B. Casale is named on this Form 483, for the inspection of Mar 9 – Mar 12, 2015. Each investigator has a profile showing what they cite most.
When was The Wellness Pharmacy, LLC inspected by FDA?
The inspection ran Mar 9 – Mar 12, 2015, and the Form 483 is dated March 12, 2015.
How do I get the full Form 483 for The Wellness Pharmacy, LLC?
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.