Atlas

Form 483

Manfacturing Technology and Services, LLC Form 483, 2019-07-31

FDA issued a Form 483 to Manfacturing Technology and Services, LLC on 2019-07-31 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Manfacturing Technology and Services, LLC · Oxford, United States · Issued July 31, 2019

Overview

  • 6 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.

31 Jul 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Wendy R Blame

31 Jul 2019
21 CFR 820.198(b)

Rationale documented for no investigation

Cited by Wendy R Blame

31 Jul 2019
21 CFR 820.70(i)

Software validation for automated processes

Cited by Wendy R Blame

31 Jul 2019
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Wendy R Blame

31 Jul 2019
21 CFR 820.198(b)

Rationale documented for no investigation

Cited by Wendy R Blame

Inspected site

MTManfacturing Technology and Services, LLCOxford, United States

Inspection team

WRWendy R Blame

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(b)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(i)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