Drug factory · FDA FEI 1220423

Genzyme Corporation

45 New York Avenue, Framingham, MA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Nov 21, 2014 inspection

• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contract drug products--lack of responsibility 21 CFR 211.22(a)
  The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Who must report - manufacturer 21 CFR 600.14(a)(1)
  Failure to submit biological deviation reports.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.
• Biological product deviation report 21 CFR 606.171
  Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred.

Registered with FDA for: analysis; api manufacture; manufacture.