Regulatory Filing & Pre- License/Pre-Approval Inspections of ...

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Inspection Classification‣No action indicated (NAI)• Form FDA 483 not issued, EIR written‣Voluntary action indicated (VAI)• Form FDA 483 issued• Responsible person must respond regardingobservations‣Non-concur approval• Non approval <strong>of</strong> BLA or supplement• Manufacturer has opportunity to correct28
Inspection Outcome & <strong>Approval</strong>‣A response to 483 observations is required inorder to receive approval & licensing‣Response to 483 observations must be sentwithin 15 business days‣DMPQ reviews response and providesrecommendation for final action29
Page 1 and 2: Regulatory Filing & Pre-License/Pre
Page 3 and 4: Regulatory Authority3
Page 6: 21 CFR Part 601 - LicensingRelevant
Page 9 and 10: “Specified” Biological Products
Page 11 and 12: 21 CFR 601.20 - Biologics licenses;
Page 13 and 14: Organization13
Page 16 and 17: Division of Manufacturing and Produ
Page 18 and 19: BMT Review of a BLADrug Substance
Page 20: BMT Review of a BLADrug Product (co
Page 23 and 24: Review Issues‣ Bulk thaw & hold l
Page 25 and 26: Purpose of Inspection‣Meet statut
Page 27: Inspection StrategySystems-based‣
Page 31 and 32: Quality Oversight‣Inadequate qual
Page 33 and 34: SOPs‣ SOPs are not executed consi
Page 35 and 36: Utilities‣High bioburden counts f
Page 37 and 38: Production‣Discrepancies between
Page 39 and 40: Laboratory‣Assays not appropriate
Page 41 and 42: Additional Information/Resources‣
Page 43: Contact InformationAnastasia Lolas3

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