Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy
Form 483 issued June 27, 2018 · Las Vegas, Nevada
- Inspection
- Jun 25 – Jun 27, 2018
- Investigator
- Ashar P. Parikh
- Observations
- 3
- Pages
- 2
- FEI number
- 3012289984
In short: On June 27, 2018, FDA issued a Form 483 with 3 observations to Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy in Las Vegas, Nevada (FEI 3012289984) after an inspection that ran Jun 25 – Jun 27, 2018. The investigator was Ashar P. Parikh. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 3 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established…
- 02
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 03
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) 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 211.84
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 3 observations on this Form 483, mostly about materials and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy?
Ashar P. Parikh is named on this Form 483, for the inspection of Jun 25 – Jun 27, 2018. 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 Jun 25 – Jun 27, 2018, and the Form 483 is dated June 27, 2018.
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.