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Form 483

Shilpa Medicare Limited Form 483, 2015-08-26

FDA issued a Form 483 to Shilpa Medicare Limited on 2015-08-26 with 18 public-safe observations.

483· Form 483 issuedHuman Drugs18 observations

Shilpa Medicare Limited · Jadcherla, Mahabubnagar District, India · Issued August 26, 2015

Overview

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

Inspectional observations

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

26 Aug 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters

26 Aug 2015
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters

26 Aug 2015
21 CFR 211.188(b)(10)

Records of any sampling performed

Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters

26 Aug 2015
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters

26 Aug 2015
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Felix Maldonado, Meisha R Sampson, Tajah L Blackburn, Meisha R Waters

Inspected site

SMShilpa Medicare LimitedJadcherla, Mahabubnagar District, India

Inspection team

FMFelix Maldonado
MRMeisha R Sampson
TLTajah L Blackburn
MRMeisha R Waters

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(10)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.52Cited across public-safe Form 483 observations2x
21 CFR 211.56(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(c)Cited across public-safe Form 483 observations2x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 18 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