Form 483

Strive Pharmacy Texas LLC dba Strive Pharmacy Form 483, 2023-09-08

FDA issued a Form 483 to Strive Pharmacy Texas LLC dba Strive Pharmacy on 2023-09-08 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Strive Pharmacy Texas LLC dba Strive Pharmacy · Boerne, United States · Issued September 8, 2023

Overview

  • 3 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.

8 Sep 2023
FDCA 501(a)(2)(A)

Facility design, influx of lesser quality air

Cited by Camerson E Moore

8 Sep 2023
FDCA 501(a)(2)(A)

Failure to clean and disinfect/sterilize equipment, ISO 5 area

Cited by Camerson E Moore

8 Sep 2023
FDCA 501(a)(2)(A)

Personnel exposure during aseptic manipulations

Cited by Camerson E Moore

Inspected site

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 observations3x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 3 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