Form 483

MTR Foods Private Limited Form 483, 2016-07-12

FDA issued a Form 483 to MTR Foods Private Limited on 2016-07-12 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

MTR Foods Private Limited · Bangalore, India · Issued July 12, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 5 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.

12 Jul 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Robert D Ogan

12 Jul 2016
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Robert D Ogan

12 Jul 2016
21 CFR 110.35(d)

Failure to clean - general

Cited by Robert D Ogan

12 Jul 2016
21 CFR 110.35(d)

Failure to clean - general

Cited by Robert D Ogan

12 Jul 2016
21 CFR 110.37(b)(5)

Backflow prevention

Cited by Robert D Ogan

Inspected site

MFMTR Foods Private LimitedBangalore, India

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(a)Cited across public-safe Form 483 observations4x
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)Cited across public-safe Form 483 observations2x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 113.60(d)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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