FDA Intel

Stonegate Pharmacy LP

Form 483 issued March 2, 2016 · Aus t i n, Texas

Inspection
Feb 23 – Mar 2, 2016
Investigator
Patty P. Kaewussdangkul
Observations
12
Pages
8
FEI number
3012038236

In short: On March 2, 2016, FDA issued a Form 483 with 12 observations to Stonegate Pharmacy LP in Aus t i n, Texas (FEI 3012038236) after an inspection that ran Feb 23 – Mar 2, 2016. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment4
Laboratory controls3
Production2
Materials2
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…

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

    Aseptic processing areas are deficient regarding the system…

  3. 03
    21 CFR 211.42(c)(10)(v)

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

  4. 04
    21 CFR 211.28(a)

    Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for…

8 more observations

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

Get the full 483

This inspection in context

The investigator

Patty P. Kaewussdangkul

54 documents · 2006–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.

The firm

Stonegate Pharmacy LP history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Stonegate Pharmacy LP?

FDA listed 12 observations on this Form 483, mostly about facilities & equipment, laboratory controls 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 Stonegate Pharmacy LP?

Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Feb 23 – Mar 2, 2016. Each investigator has a profile showing what they cite most.

When was Stonegate Pharmacy LP inspected by FDA?

The inspection ran Feb 23 – Mar 2, 2016, and the Form 483 is dated March 2, 2016.

How do I get the full Form 483 for Stonegate Pharmacy LP?

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