Form 483

AnazaoHealth Corporation Form 483, 2025-08-08

FDA issued a Form 483 to AnazaoHealth Corporation on 2025-08-08 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

AnazaoHealth Corporation · Las Vegas, United States · Issued August 8, 2025

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

8 Aug 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Taichun Qin

8 Aug 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Taichun Qin

8 Aug 2025
21 CFR 211.194(a)

Complete test data included in records

Cited by Taichun Qin

8 Aug 2025
21 CFR 211.198(b)(2)

Complaint Investigation/Follow-Up Findings

Cited by Taichun Qin

Inspected site

ACAnazaoHealth CorporationLas Vegas, 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 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited 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 4 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