Atlas

Form 483

Bhakti, Inc. Form 483, 2018-08-15

FDA issued a Form 483 to Bhakti, Inc. on 2018-08-15 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Bhakti, Inc. · Westminster, United States · Issued August 15, 2018

Overview

  • 2 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.

15 Aug 2018
21 CFR 117.145(b)

Process Controls Monitoring Frequency

Cited by Carla R Hinz

15 Aug 2018
21 CFR 120.24(a)

Process controls - HACCP plan - 5 log reduction

Cited by Carla R Hinz

Inspected site

BIBhakti, Inc.Westminster, United States

Inspection team

CRCarla R Hinz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(b)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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