Southern Tier Home Infusion, Inc. dba Pharmacy Innovations
Form 483 issued November 30, 2022 · Erie, Pennsylvania
- Inspection
- Nov 2 – Nov 30, 2022
- Investigator
- Jazmine N. Brown
- Observations
- 9
- Pages
- 8
- FEI number
- 3004858203
In short: On November 30, 2022, FDA issued a Form 483 with 9 observations to Southern Tier Home Infusion, Inc. dba Pharmacy Innovations in Erie, Pennsylvania (FEI 3004858203) after an inspection that ran Nov 2 – Nov 30, 2022. The investigator was Jazmine N. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 9 of 9 observations.
Most cited: 21 CFR 211.113 (5×) · 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is inadequate HEPA filter coverage or airflow over the area to which…
- 02
Media fills were not performed that closely simulated aseptic production operations incorporating, as appropriate, worst-case activities…
- 03
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within…
- 04
The facility design was observed to allow the influx of poor quality air…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmSouthern Tier Home Infusion, Inc. dba Pharmacy Innovations history
All 2 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 Southern Tier Home Infusion, Inc. dba Pharmacy Innovations?
FDA listed 9 observations on this Form 483, mostly about production and facilities & equipment. 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 Southern Tier Home Infusion, Inc. dba Pharmacy Innovations?
Jazmine N. Brown is named on this Form 483, for the inspection of Nov 2 – Nov 30, 2022. Each investigator has a profile showing what they cite most.
When was Southern Tier Home Infusion, Inc. dba Pharmacy Innovations inspected by FDA?
The inspection ran Nov 2 – Nov 30, 2022, and the Form 483 is dated November 30, 2022.
How do I get the full Form 483 for Southern Tier Home Infusion, Inc. dba Pharmacy Innovations?
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.