Surgery Pharmacy Services, Inc.
Form 483 issued July 7, 2023 · Chattanooga, Tennessee
- Inspection
- Jun 20 – Jul 7, 2023
- Investigator
- Jared P. Stevens
- Observations
- 3
- Pages
- 3
- FEI number
- 3010704905
In short: On July 7, 2023, FDA issued a Form 483 with 3 observations to Surgery Pharmacy Services, Inc. in Chattanooga, Tennessee (FEI 3010704905) after an inspection that ran Jun 20 – Jul 7, 2023. The investigator was Jared P. Stevens. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
Smoke studies were inadequately…
- 02FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
- 03
Your facility is designed and operated in a way that may permit the influx of lesser…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmSurgery Pharmacy Services, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Surgery Pharmacy Services, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. 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 Surgery Pharmacy Services, Inc.?
Jared P. Stevens is named on this Form 483, for the inspection of Jun 20 – Jul 7, 2023. Each investigator has a profile showing what they cite most.
When was Surgery Pharmacy Services, Inc. inspected by FDA?
The inspection ran Jun 20 – Jul 7, 2023, and the Form 483 is dated July 7, 2023.
How do I get the full Form 483 for Surgery Pharmacy Services, Inc.?
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.