Atlas

Form 483

Innovative Medical Manufacturing Co. Form 483, 2015-01-29

FDA issued a Form 483 to Innovative Medical Manufacturing Co. on 2015-01-29 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Innovative Medical Manufacturing Co. · Chunan, Taiwan · Issued January 29, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

29 Jan 2015
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Leighton K Ngai

29 Jan 2015
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Leighton K Ngai

29 Jan 2015
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Leighton K Ngai

29 Jan 2015
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Leighton K Ngai

29 Jan 2015
21 CFR 820.75(a)

Documentation

Cited by Leighton K Ngai

Inspected site

IMInnovative Medical Manufacturing Co.Chunan, Taiwan

Inspection team

LKLeighton K Ngai

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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