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Form 483

Strides Pharma Science Limited Form 483, 2020-01-17

FDA issued a Form 483 to Strides Pharma Science Limited on 2020-01-17 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Strides Pharma Science Limited · Bangalore, India · Issued January 17, 2020

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.

17 Jan 2020
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Marcellinus D Dordunoo

Inspected site

SPStrides Pharma Science LimitedBangalore, India

Inspection team

MDMarcellinus D Dordunoo

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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