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Form 483

Strides Pharma Science Limited Form 483, 2024-04-05

FDA issued a Form 483 to Strides Pharma Science Limited on 2024-04-05 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Strides Pharma Science Limited · Chengalpattu, India · Issued April 5, 2024

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are 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 Apr 2024
21 CFR 211.180(c)

Records not made readily available to FDA

Cited by Steven A Brettler

5 Apr 2024
21 CFR 211.188(b)(12)

Investigations made into any unexplained discrepancy

Cited by Steven A Brettler

Inspected site

SPStrides Pharma Science LimitedChengalpattu, India

Inspection team

SASteven A Brettler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.180(c)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(12)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

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