Form 483

Forest Ambulatory Surgical Associates, LP Form 483, 2015-03-05

FDA issued a Form 483 to Forest Ambulatory Surgical Associates, LP on 2015-03-05 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Forest Ambulatory Surgical Associates, LP · San Jose, United States · Issued March 5, 2015

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

5 Mar 2015
21 CFR 1271.265(d)

Shipping conditions appropriate

Cited by Laverne Puckett

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.265(d)Cited across public-safe Form 483 observations1x

Full 483 report

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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