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Form 483

Associates of Cape Cod, Inc. Form 483, 2025-04-03

FDA issued a Form 483 to Associates of Cape Cod, Inc. on 2025-04-03 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Associates of Cape Cod, Inc. · East Falmouth, United States · Issued April 3, 2025

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.

3 Apr 2025
21 CFR 211.180(e)

Records reviewed annually

Cited by Burnell M Henry

Inspected site

AOAssociates of Cape Cod, Inc.East Falmouth, United States

Inspection team

BMBurnell M Henry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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  • 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