PCP LV LLC dba Pinnacle Compounding Pharmacy
Form 483 issued July 31, 2015 · Las Ve as, Nevada
- Inspection
- Jul 27 – Jul 31, 2015
- Investigator
- Anh Lac
- Observations
- 10
- Pages
- 6
- FEI number
- 3011656880
In short: On July 31, 2015, FDA issued a Form 483 with 10 observations to PCP LV LLC dba Pinnacle Compounding Pharmacy in Las Ve as, Nevada (FEI 3011656880) after an inspection that ran Jul 27 – Jul 31, 2015. The investigator was Anh Lac. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPCP LV LLC dba Pinnacle Compounding Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.28(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PCP LV LLC dba Pinnacle Compounding Pharmacy?
FDA listed 10 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 PCP LV LLC dba Pinnacle Compounding Pharmacy?
Anh Lac is named on this Form 483, for the inspection of Jul 27 – Jul 31, 2015. Each investigator has a profile showing what they cite most.
When was PCP LV LLC dba Pinnacle Compounding Pharmacy inspected by FDA?
The inspection ran Jul 27 – Jul 31, 2015, and the Form 483 is dated July 31, 2015.
How do I get the full Form 483 for PCP LV LLC dba Pinnacle 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.