Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy)
Form 483 issued April 4, 2018 · Phoenix, Arizona
- Inspection
- Mar 26 – Apr 4, 2018
- Investigator
- Zachery L. Miller
- Observations
- 5
- Pages
- 3
- FEI number
- 3007816026
In short: On April 4, 2018, FDA issued a Form 483 with 5 observations to Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy) in Phoenix, Arizona (FEI 3007816026) after an inspection that ran Mar 26 – Apr 4, 2018. The investigator was Zachery L. Miller. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You had inadequate HEPA filter coverage and airflow over the area which…
- 02
Disinfecting agents and cleaning wipes used in the ISO 5 Classified aseptic processing…
- 03
Personnel engaged in aseptic processing were observed…
- 04
Media fill studies are not conducted to closely…
This inspection in context
Zachery L. Miller
17 documents · 2011–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Colorado.
The firmVitalab Pharmacy, Incorporated (dba Vasco 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy)?
FDA listed 5 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy)?
Zachery L. Miller is named on this Form 483, for the inspection of Mar 26 – Apr 4, 2018. Each investigator has a profile showing what they cite most.
When was Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy) inspected by FDA?
The inspection ran Mar 26 – Apr 4, 2018, and the Form 483 is dated April 4, 2018.
How do I get the full Form 483 for Vitalab Pharmacy, Incorporated (dba Vasco 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.