Stonegate Pharmacy LP
Form 483 issued August 9, 2019 · Austin, Texas
- Inspection
- Jul 30 – Aug 9, 2019
- Investigator
- Jason R. Caballero
- Observations
- 5
- Pages
- 7
- FEI number
- 3012038236
In short: On August 9, 2019, FDA issued a Form 483 with 5 observations to Stonegate Pharmacy LP in Austin, Texas (FEI 3012038236) after an inspection that ran Jul 30 – Aug 9, 2019. The investigator was Jason R. Caballero. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (4×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 02FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate containment and…
- 03FDCA 501(a)(2)(A)
Equipment was and Materials or supplies were not disinfected prior to entering…
- 04FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean and…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stonegate Pharmacy LP?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Stonegate Pharmacy LP?
Jason R. Caballero is named on this Form 483, for the inspection of Jul 30 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Stonegate Pharmacy LP inspected by FDA?
The inspection ran Jul 30 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
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.