Atlas

Form 483

Servapure Company Form 483, 2010-06-01

FDA issued a Form 483 to Servapure Company on 2010-06-01 with 6 public-safe observations.

483· Form 483 issued6 observations

Servapure Company · Bay City, United States · Issued June 1, 2010

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.

1 Jun 2010
21 CFR 820.22

Quality audits - auditor independence

Cited by Brian P Putz

1 Jun 2010
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Brian P Putz

1 Jun 2010
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Brian P Putz

1 Jun 2010
21 CFR 820.198(a)

Complaints

Cited by Brian P Putz

1 Jun 2010
21 CFR 820.198(b)

Review and evaluation for investigation

Cited by Brian P Putz

Inspected site

SCServapure CompanyBay City, United States

Inspection team

BPBrian P Putz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(b)Cited across public-safe Form 483 observations1x
21 CFR 820.200(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(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