Form 483

APL HEALTHCARE LIMITED Form 483, 2020-02-28

FDA issued a Form 483 to APL HEALTHCARE LIMITED on 2020-02-28 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

APL HEALTHCARE LIMITED · Naidupeta, India · Issued February 28, 2020

Overview

  • 2 public-safe observations are 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.

28 Feb 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Farhana Khan

28 Feb 2020
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Farhana Khan

Inspected site

AHAPL HEALTHCARE LIMITEDNaidupeta, India

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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