Banner Pharmacy Services, LLC
Form 483 issued September 20, 2017 · Chandler, Arizona
- Inspection
- Sep 11 – Sep 20, 2017
- Investigators
- Ashar P. Parikh· Eileen A. Liu· Nicholas L. Hunt
- Observations
- 13
- Pages
- 15
- FEI number
- 3009422393
In short: On September 20, 2017, FDA issued a Form 483 with 13 observations to Banner Pharmacy Services, LLC in Chandler, Arizona (FEI 3009422393) after an inspection that ran Sep 11 – Sep 20, 2017. The investigators were Ashar P. Parikh, Eileen A. Liu and Nicholas L. Hunt. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and…
- 02
Results of stability testing are not used…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Banner Pharmacy Services, LLC?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, facilities & equipment 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?
Ashar P. Parikh, Eileen A. Liu and Nicholas L. Hunt are named on this Form 483, for the inspection of Sep 11 – Sep 20, 2017. Each investigator has a profile showing what they cite most.
When was Banner Pharmacy Services, LLC inspected by FDA?
The inspection ran Sep 11 – Sep 20, 2017, and the Form 483 is dated September 20, 2017.
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.