Banner Pharmacy Services, LLC
Form 483 issued March 20, 2015 · Chandler, Arizona
- Inspection
- Mar 16 – Mar 20, 2015
- Investigator
- Marcus F. Yambot
- Observations
- 11
- Pages
- 7
- FEI number
- 3009422393
In short: On March 20, 2015, FDA issued a Form 483 with 11 observations to Banner Pharmacy Services, LLC in Chandler, Arizona (FEI 3009422393) after an inspection that ran Mar 16 – Mar 20, 2015. The investigator was Marcus F. Yambot. 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.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Marcus F. Yambot
16 documents · 2009–2023
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmBanner Pharmacy Services, LLC 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(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Banner Pharmacy Services, LLC?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Banner Pharmacy Services, LLC?
Marcus F. Yambot is named on this Form 483, for the inspection of Mar 16 – Mar 20, 2015. Each investigator has a profile showing what they cite most.
When was Banner Pharmacy Services, LLC inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2015, and the Form 483 is dated March 20, 2015.
How do I get the full Form 483 for Banner Pharmacy Services, LLC?
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.