Enforcement The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law (e.g., the content of guidance documents and the cGMPs). Here are some examples where such enforcement has occurred that included departures from GDP : Documentation not contemporaneous US FDAWarning Letter 320-11-20 (UCM271708) to Yag-Mag Labs Private Limited (Hyderabad, India), 12 September 2011 US FDA . "Warning Letter" UCM271708. Observation #1 - Accessed 27 June 2013 US FDA Warning Letter UCM172108 to Caraco Pharmaceutical Laboratories, Ltd. (Caraco), 12 May 2009 Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a - Accessed 1 June 2011 US FDA Warning Letter UCM076496 to Kunshan Chemical and Pharmaceutical Co., Ltd. (Kunshan City, Jiangsu, China), 6 September 2007 US FDA. "Warning Letter" UCM076496. Observation #1 - Accessed 16 August 2012 US FDA Warning Letter UCM075472 to Litron Laboratories, Ltd. (Rochester, NY), 1 July 2005 US FDA. "Warning Letter" UCM075472 . Observation #4 - Accessed 16 August 2012 Use of ditto marks US FDAWarning Letter FLA-99-29 to All Medicare Home Aids, Inc. , 28 January 1999.US FDA. "Warning Letter" FLA-99-29 Use of signature stamp US FDA Warning Letter UCM075960 to Scott A.Spiro, MD, 28 June 2006. US FDA. "Warning Letter" UCM075960 - Accessed 4 February 2010 US FDAWarning Letter UCM066113 to Medtronic, Inc. , 2 December 1997US FDA. "Warning Letter" UCM066113 Obscured original data US FDAWarning Letter UCM069041 to SOL Pharmaceuticals Limited, 21 November 2000US FDA . "Warning Letter" UCM069041 US FDA Warning Letter UCM076246 to Gynetics Medical Products NV, 16 January 2007US FDA. "Warning Letter" UCM076246, Observation #13b. - Accessed 1 June 2011 Use of pencil US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, 21 November 2000 US FDA Warning Letter UCM221006 to Haw Par Healthcare Limited (Singapore), 20 July 2010US FDA. "Warning Letter" UCM221006. Observation #7.b. - Accessed 16 August 2012 Inaccurate recordsUS FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, 21 November 2000%DIFDELCMD < %DIFDELCMD < %%% Hand changes not dated Form FDA 483 issued to L.Perrigo Co., 7 November 2008. US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A
Enforcement The competent authorities are empowered to inspect establishments to enforce the law and the interpretations of the law (e.g., the content of guidance documents and the cGMPs). Departures from GDP that involved the regulator have included: documentation not contemporaneousUS FDA . "Warning Letter" UCM271708. Observation #1 - Accessed 27 June 2013Caraco Pharmaceutical Laboratories, Ltd. Response to the FDA's May 12, 2009, 483. Observation #14a - Accessed 1 June 2011 , use of ditto marksUS FDA. "Warning Letter" FLA-99-29 , signature stamps. US FDA. "Warning Letter" UCM075960 - Accessed 4 February 2010US FDA. "Warning Letter" UCM066113 , obscured original dataUS FDA . "Warning Letter" UCM069041 , Use of pencil %DIFDELCMD < %DIFDELCMD < %%% , inaccurate records, and not dating changes. US FDA. Form FDA 483 issued to L. Perrigo Co., dated 11/07/2008. Observation #9A
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Here are some examples where such enforcement has occurred that included departures from GDP :
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Documentation not contemporaneous US FDAWarning Letter 320-11-20 (UCM271708) to Yag-Mag Labs Private Limited (Hyderabad, India), 12 September 2011 US FDA
Departures from GDP that involved the regulator have included: documentation not contemporaneousUS FDA
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2013 US FDA Warning Letter UCM172108 to Caraco
2013Caraco
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(Caraco), 12 May 2009 Caraco Pharmaceutical Laboratories, Ltd.
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US FDA Warning Letter UCM076496 to Kunshan Chemical and Pharmaceutical Co., Ltd. (Kunshan City, Jiangsu, China), 6 September 2007 US FDA. "Warning Letter" UCM076496. Observation #1 - Accessed 16 August 2012 US FDA Warning Letter UCM075472 to Litron Laboratories, Ltd. (Rochester, NY), 1 July 2005 US FDA. "Warning Letter" UCM075472 . Observation #4 - Accessed 16 August 2012
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Use of ditto marks US FDAWarning Letter FLA-99-29 to All Medicare Home Aids, Inc.
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28 January 1999.US FDA.
use of ditto marksUS FDA.
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Use of signature stamp US FDA Warning Letter UCM075960 to Scott A.Spiro, MD, 28 June 2006.
, signature stamps.
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2010 US FDAWarning Letter UCM066113 to Medtronic, Inc. , 2 December 1997US FDA.
2010US FDA.
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Obscured original data US FDAWarning Letter UCM069041 to SOL Pharmaceuticals Limited, 21 November 2000US FDA
, obscured original dataUS FDA
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US FDA Warning Letter UCM076246 to Gynetics Medical Products NV, 16 January 2007US FDA. "Warning Letter" UCM076246, Observation #13b. - Accessed 1 June 2011
,
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US FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, 21 November 2000 US FDA Warning Letter UCM221006 to Haw Par Healthcare Limited (Singapore), 20 July 2010US FDA. "Warning Letter" UCM221006. Observation #7.b. - Accessed 16 August 2012
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Inaccurate recordsUS FDA Warning Letter 320-01-02 to SOL Pharmaceuticals Limited, 21 November 2000
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Hand changes not dated Form FDA 483 issued to L.Perrigo Co., 7 November 2008.
, inaccurate records, and not dating changes.