Atlas

Form 483

Innovative Medical Manufacturing Co. Form 483, 2010-08-12

FDA issued a Form 483 to Innovative Medical Manufacturing Co. on 2010-08-12 with 2 public-safe observations.

483· Form 483 issued2 observations

Innovative Medical Manufacturing Co. · Chunan, Taiwan · Issued August 12, 2010

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.

12 Aug 2010
21 CFR 820.30(j)

Design history file

Cited by Stephen D Eich

12 Aug 2010
21 CFR 820.184

DHR content

Cited by Stephen D Eich

Inspected site

IMInnovative Medical Manufacturing Co.Chunan, Taiwan

Inspection team

SDStephen D Eich

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)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