Prescription Lab Compounding Pharmacy
Form 483 issued September 10, 2015 · Tucs on, Arizona
- Inspection
- Aug 31 – Sep 10, 2015
- Investigator
- Caryn M. McNab
- Observations
- 4
- Pages
- 2
- FEI number
- 3004578527
In short: On September 10, 2015, FDA issued a Form 483 with 4 observations to Prescription Lab Compounding Pharmacy in Tucs on, Arizona (FEI 3004578527) after an inspection that ran Aug 31 – Sep 10, 2015. The investigator was Caryn M. McNab. 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 3 of 4 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Caryn M. McNab
7 documents · 2013–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPrescription Lab Compounding Pharmacy history
All 4 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 Prescription Lab Compounding Pharmacy?
FDA listed 4 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 Prescription Lab Compounding Pharmacy?
Caryn M. McNab is named on this Form 483, for the inspection of Aug 31 – Sep 10, 2015. Each investigator has a profile showing what they cite most.
When was Prescription Lab Compounding Pharmacy inspected by FDA?
The inspection ran Aug 31 – Sep 10, 2015, and the Form 483 is dated September 10, 2015.
How do I get the full Form 483 for Prescription Lab 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.