Stonegate Pharmacy LP
Form 483 issued June 11, 2020 · Austin, Texas
- Inspection
- May 30, 2018 – Jun 11, 2020
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 4
- Pages
- 3
- FEI number
- 3012038236
In short: On June 11, 2020, FDA issued a Form 483 with 4 observations to Stonegate Pharmacy LP in Austin, Texas (FEI 3012038236) after an inspection that ran May 30, 2018 – Jun 11, 2020. The investigator was Patty P. Kaewussdangkul. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
4 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Personnel hand washing proced ure was conducted in a way that may have cause the gowning…
- 03
are not used properly to verify the adequacy of…
- 04
Stock solutions used in the preparation of sterile finished drug products are not (b) (4)sterilized nor…
This inspection in context
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 firmStonegate Pharmacy LP history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stonegate Pharmacy LP?
FDA listed 4 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). 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 May 30, 2018 – Jun 11, 2020. Each investigator has a profile showing what they cite most.
When was Stonegate Pharmacy LP inspected by FDA?
The inspection ran May 30, 2018 – Jun 11, 2020, and the Form 483 is dated June 11, 2020.
How do I get the full Form 483 for Stonegate Pharmacy LP?
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.