Guardian Pharmacy Services
Form 483 issued October 21, 2016 · Dallas, Texas
- Inspection
- Sep 12 – Oct 21, 2016
- Investigators
- Anh Lac· Patrice S. Hall
- Observations
- 8
- Pages
- 9
- FEI number
- 3012669715
In short: On October 21, 2016, FDA issued a Form 483 with 8 observations to Guardian Pharmacy Services in Dallas, Texas (FEI 3012669715) after an inspection that ran Sep 12 – Oct 21, 2016. The investigators were Anh Lac and Patrice S. Hall. 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 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guardian Pharmacy Services?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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?
Anh Lac and Patrice S. Hall are named on this Form 483, for the inspection of Sep 12 – Oct 21, 2016. Each investigator has a profile showing what they cite most.
When was Guardian Pharmacy Services inspected by FDA?
The inspection ran Sep 12 – Oct 21, 2016, and the Form 483 is dated October 21, 2016.
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.