Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy
Form 483 issued May 12, 2016 · Las Vegas, Nevada
- Inspection
- May 2 – May 12, 2016
- Investigators
- David Eng· Eileen A. Liu· Rumany C. Penn
- Observations
- 11
- Pages
- 8
- FEI number
- 3012289984
In short: On May 12, 2016, FDA issued a Form 483 with 11 observations to Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy in Las Vegas, Nevada (FEI 3012289984) after an inspection that ran May 2 – May 12, 2016. The investigators were David Eng, Eileen A. Liu and Rumany C. Penn. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 8 of 11 observations.
Most cited: 21 CFR 211.42 (4×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient in that walls and ceilings are not smooth and/or hard surfaces…
- 03
The flow of components, drug product containers, closures, in-process materials, and drug products though the building…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
David Eng
5 documents · 2015–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmWell Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy?
David Eng, Eileen A. Liu and Rumany C. Penn are named on this Form 483, for the inspection of May 2 – May 12, 2016. Each investigator has a profile showing what they cite most.
When was Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy inspected by FDA?
The inspection ran May 2 – May 12, 2016, and the Form 483 is dated May 12, 2016.
How do I get the full Form 483 for Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy?
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.