Form 483

Bostal LLC Form 483, 2018-05-23

FDA issued a Form 483 to Bostal LLC on 2018-05-23 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Bostal LLC · Edison, United States · Issued May 23, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

23 May 2018
21 CFR 211.192

No written record of investigation

Cited by Melissa T Roy, Emmanuel J Ramos, Youmin Wang

Inspected site

BLBostal LLCEdison, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

The source PDF, 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