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Form 483

Citra Labs, LLC Form 483, 2017-09-27

FDA issued a Form 483 to Citra Labs, LLC on 2017-09-27 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

Citra Labs, LLC · Braintree, United States · Issued September 27, 2017

Overview

  • 8 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.

27 Sep 2017
21 CFR 211.182

Written records kept in individual logs

Cited by Edmund F Mrak

27 Sep 2017
21 CFR 211.182

Written records kept in individual logs

Cited by Edmund F Mrak

27 Sep 2017
21 CFR 211.186(b)(9)

Manufacturing Instructions and Specifications

Cited by Edmund F Mrak

27 Sep 2017
21 CFR 211.186(b)(9)

Manufacturing Instructions and Specifications

Cited by Edmund F Mrak

27 Sep 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Edmund F Mrak

Inspected site

CLCitra Labs, LLCBraintree, United States

Inspection team

EFEdmund F Mrak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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