Atlas

Form 483

Aveta Biomics Form 483, 2019-03-01

FDA issued a Form 483 to Aveta Biomics on 2019-03-01 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Aveta Biomics · Bedford, United States · Issued March 1, 2019

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 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.

1 Mar 2019
21 CFR 111.20(c)(3)

Physical plant - separate areas for products

Cited by John P Shelton

1 Mar 2019
21 CFR 111.20(c)(3)

Physical plant - separate areas for products

Cited by John P Shelton

1 Mar 2019
21 CFR 111.453

Written procedures - holding

Cited by John P Shelton

1 Mar 2019
21 CFR 111.453

Written procedures - holding

Cited by John P Shelton

1 Mar 2019
21 CFR 111.453

Written procedures - holding

Cited by John P Shelton

Inspected site

ABAveta BiomicsBedford, United States

Inspection team

JPJohn P Shelton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.453Cited across public-safe Form 483 observations4x
21 CFR 111.20(c)(3)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 observations

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