Form 483

Mayway Corporation Form 483, 2019-09-26

FDA issued a Form 483 to Mayway Corporation on 2019-09-26 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Mayway Corporation · Oakland, United States · Issued September 26, 2019

Overview

  • 8 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.

26 Sep 2019
21 CFR 111.105

Ensure quality; package, labeled, master record

Cited by Capri R Woolridge

26 Sep 2019
21 CFR 111.105

Ensure quality; package, labeled, master record

Cited by Capri R Woolridge

26 Sep 2019
21 CFR 111.30(c)

Equipment - automated - calibrate, inspect

Cited by Capri R Woolridge

26 Sep 2019
21 CFR 111.30(c)

Equipment - automated - calibrate, inspect

Cited by Capri R Woolridge

26 Sep 2019
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Capri R Woolridge

Inspected site

MCMayway CorporationOakland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.70(e)Cited across public-safe Form 483 observations4x
21 CFR 111.105Cited across public-safe Form 483 observations2x
21 CFR 111.30(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

The full inspection record, as Atlas holds it, 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