Form 483

Haldiram Snacks Pvt. Ltd. Form 483, 2015-05-13

FDA issued a Form 483 to Haldiram Snacks Pvt. Ltd. on 2015-05-13 with 18 public-safe observations.

483· Form 483 issuedFoods & Cosmetics18 observations

Haldiram Snacks Pvt. Ltd. · Dadri, India · Issued May 13, 2015

Overview

  • 18 public-safe observations are available for this inspection.
  • 7 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.

13 May 2015
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Mark E Farrell

13 May 2015
21 CFR 113.100(b)

Review not signed/dated

Cited by Mark E Farrell

13 May 2015
21 CFR 113.40(j)

Critical factors - frequency measured, recorded

Cited by Mark E Farrell

13 May 2015
21 CFR 113.40(j)

Other systems: Commercial sterility

Cited by Mark E Farrell

13 May 2015
21 CFR 113.40(j)

Processing: conform to other systems

Cited by Mark E Farrell

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.40(j)Cited across public-safe Form 483 observations6x
21 CFR 108.35(c)(3)(i)Cited across public-safe Form 483 observations2x
21 CFR 113.100(b)Cited across public-safe Form 483 observations2x
21 CFR 113.60(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 113.60(c)Cited across public-safe Form 483 observations2x
21 CFR 113.87(b)Cited across public-safe Form 483 observations2x
21 CFR 113.89Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 18 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