Form 483

Health Specialty Form 483, 2023-11-30

FDA issued a Form 483 to Health Specialty on 2023-11-30 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Health Specialty · Santa Fe Springs, United States · Issued November 30, 2023

Overview

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

Inspectional observations

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

30 Nov 2023
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Saied A Asbagh

30 Nov 2023
21 CFR 211.165(e)

Test methods

Cited by Saied A Asbagh

30 Nov 2023
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Saied A Asbagh

30 Nov 2023
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Saied A Asbagh

30 Nov 2023
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Saied A Asbagh

Inspected site

HSHealth SpecialtySanta Fe Springs, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

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 6 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