Surgery Pharmacy Services, Inc.
Form 483 issued December 6, 2019 · Chattanooga, Tennessee
- Inspection
- Nov 18 – Dec 6, 2019
- Investigator
- Samantha J. Bradley
- Observations
- 10
- Pages
- 3
- FEI number
- 3010704905
In short: On December 6, 2019, FDA issued a Form 483 with 10 observations to Surgery Pharmacy Services, Inc. in Chattanooga, Tennessee (FEI 3010704905) after an inspection that ran Nov 18 – Dec 6, 2019. The investigator was Samantha J. Bradley. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 10 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 211.28 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Actionable microbial contamination was present in the ISO 5 area or in adjacent areas during aseptic…
- 02
Personnel failed to disinfect or change gloves frequently…
- 03
Personnel engaged in aseptic processing were observed with exposed…
- 04
Equipment, materials, and/or supplies are not disinfected prior to…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Surgery Pharmacy Services, Inc.?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Surgery Pharmacy Services, Inc.?
Samantha J. Bradley is named on this Form 483, for the inspection of Nov 18 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Surgery Pharmacy Services, Inc. inspected by FDA?
The inspection ran Nov 18 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
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.