FDA Intel

Guardian Pharmacy Services

Form 483 issued April 20, 2018 · Dallas, Texas

Inspection
Apr 2 – Apr 20, 2018
Investigators
Bonita S. Chester· Patty P. Kaewussdangkul
Observations
15
Pages
16
FEI number
3012669715

In short: On April 20, 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 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.

Facilities & equipment7
Quality system4
Laboratory controls3
Production1

Most cited: 21 CFR 211.68(a) (2×) · 211.192 (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  2. 02
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

  3. 03
    21 CFR 211.46(c)

    Air is recirculated to production areas, without adequate measures…

  4. 04
    21 CFR 211.63

    Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…

11 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

Guardian Pharmacy Services history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.68(a)

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 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 20, 2018.

How do I get the full Form 483 for Guardian Pharmacy Services?

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