Atlas

Form 483

Surgical Systems, Inc. Form 483, 2010-01-15

FDA issued a Form 483 to Surgical Systems, Inc. on 2010-01-15 with 2 public-safe observations.

483· Form 483 issued2 observations

Surgical Systems, Inc. · Gorham, United States · Issued January 15, 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.

15 Jan 2010
21 CFR 1271.160(b)(1)

Ensuring appropriate core requirements followed

Cited by Alois P Provost

15 Jan 2010
21 CFR 1271.260(e)

Storage temperatures recorded, maintained

Cited by Alois P Provost

Inspected site

SSSurgical Systems, Inc.Gorham, United States

Inspection team

APAlois P Provost

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.160(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.260(e)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