Form 483

Apollo Health And Beauty Care, Inc. Form 483, 2019-08-16

FDA issued a Form 483 to Apollo Health And Beauty Care, Inc. on 2019-08-16 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Apollo Health And Beauty Care, Inc. · North York, Canada · Issued August 16, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

16 Aug 2019
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Caryn M Mcnab

16 Aug 2019
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Caryn M Mcnab

16 Aug 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Caryn M Mcnab

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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 3 observations

The source PDF and every observation in full, 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