Form 483

Srinivasam Cancer Care Hospitals India Pvt Ltd Form 483, 2016-01-15

FDA issued a Form 483 to Srinivasam Cancer Care Hospitals India Pvt Ltd on 2016-01-15 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Srinivasam Cancer Care Hospitals India Pvt Ltd · Bangalore, India · Issued January 15, 2016

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

15 Jan 2016
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Jennifer C Adams, Jennifer C Johnson

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x

Full 483 report

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  • 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