Form 483

MTR Foods Private Limited Form 483, 2021-10-28

FDA issued a Form 483 to MTR Foods Private Limited on 2021-10-28 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

MTR Foods Private Limited · Bangalore, India · Issued October 28, 2021

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.

28 Oct 2021
21 CFR 113.100(b)

Review not signed/dated

Cited by Eric C Milstead

28 Oct 2021
21 CFR 113.40(a)(2)(iii)

Adjusted to agree with TID

Cited by Eric C Milstead

28 Oct 2021
21 CFR 113.60(c)

Coding - no mark, permanently visible

Cited by Eric C Milstead

28 Oct 2021
21 CFR 113.87(b)

Visual indicators not used

Cited by Eric C Milstead

Inspected site

MFMTR Foods Private LimitedBangalore, India

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(2)(iii)Cited across public-safe Form 483 observations1x
21 CFR 113.60(c)Cited across public-safe Form 483 observations1x
21 CFR 113.87(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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