Atlas

Form 483

Apotex Research Private Limited Form 483, 2024-03-15

FDA issued a Form 483 to Apotex Research Private Limited on 2024-03-15 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Apotex Research Private Limited · Bengaluru, India · Issued March 15, 2024

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

15 Mar 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Jeffrey P Raimondi, Aditi Thakur, Richmond K Yip

15 Mar 2024
21 CFR 211.192

No written record of investigation

Cited by Jeffrey P Raimondi, Aditi Thakur, Richmond K Yip

15 Mar 2024
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jeffrey P Raimondi, Aditi Thakur, Richmond K Yip

Inspected site

ARApotex Research Private LimitedBengaluru, India

Inspection team

JPJeffrey P Raimondi
ATAditi Thakur
RKRichmond K Yip

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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