Form 483

APL HEALTHCARE LIMITED Form 483, 2023-09-19

FDA issued a Form 483 to APL HEALTHCARE LIMITED on 2023-09-19 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

APL HEALTHCARE LIMITED · Naidupeta, India · Issued September 19, 2023

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.

19 Sep 2023
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Kellia N Hicks

Inspected site

AHAPL HEALTHCARE LIMITEDNaidupeta, India

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

The source PDF, 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