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Form 483

Haimen Pharma Inc. Form 483, 2019-01-12

FDA issued a Form 483 to Haimen Pharma Inc. on 2019-01-12 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Haimen Pharma Inc. · Haimen City, China · Issued January 12, 2019

Overview

  • 4 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.

12 Jan 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Roger F Zabinski

12 Jan 2019
21 CFR 211.28(b)

Habits of good sanitation & health

Cited by Roger F Zabinski

12 Jan 2019
21 CFR 211.192

Written record of investigation incomplete

Cited by Roger F Zabinski

12 Jan 2019
21 CFR 211.28(b)

Habits of good sanitation & health

Cited by Roger F Zabinski

Inspected site

HPHaimen Pharma Inc.Haimen City, China

Inspection team

RFRoger F Zabinski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.28(b)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

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