Form 483

Surgery Pharmacy Services Inc Form 483, 2023-07-07

FDA issued a Form 483 to Surgery Pharmacy Services Inc on 2023-07-07 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Surgery Pharmacy Services Inc · Chattanooga, United States · Issued July 7, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Jul 2023
FDCA 501(a)(2)(A)

Inadequate smoke studies

Cited by Jared P Stevens

7 Jul 2023
FDCA 501(a)(2)(A)

Media fills, failure

Cited by Jared P Stevens

Inspected site

SPSurgery Pharmacy Services IncChattanooga, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations2x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere