Guardian Pharmacy Services
Form 483 issued April 23, 2018 · Dallas, Texas
- Inspection
- Apr 2 – Apr 20, 2018
- Investigators
- Bonita S. Chester· Lori G. Cantin· Patty P. Kaewussdangkul
- Observations
- 15
- Pages
- 15
- FEI number
- 3012669715
In short: On April 23, 2018, FDA issued a Form 483 with 15 observations to Guardian Pharmacy Services in Dallas, Texas (FEI 3012669715) after an inspection that ran Apr 2 – Apr 20, 2018. The investigators were Bonita S. Chester, Lori G. Cantin and Patty P. Kaewussdangkul. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 11 of 15 observations.
Most cited: 21 CFR 211.192 (2×)
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 the system for cleaning and disinfecting the room and equipment…
- 03
Air is recirculated to production areas, without adequate measures to…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmGuardian Pharmacy Services history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guardian Pharmacy Services?
FDA listed 15 observations on this Form 483, mostly about facilities & equipment, quality system 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 Guardian Pharmacy Services?
Bonita S. Chester, Lori G. Cantin and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Apr 2 – Apr 20, 2018. Each investigator has a profile showing what they cite most.
When was Guardian Pharmacy Services inspected by FDA?
The inspection ran Apr 2 – Apr 20, 2018, and the Form 483 is dated April 23, 2018.
How do I get the full Form 483 for Guardian Pharmacy Services?
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.