III. BPD Reports Submitted by Manufacturers of Biological Products Other Than Blood and Blood Components (Non-Blood)

• Non-blood manufacturers submitted 30 more reports in FY08 than in the previous year (FY07-363) {Table 2}.
• Allergenic manufacturers submitted five fewer reports (FY07-174)
  • 152 of 161 (94%) of product specification reports were related to precipitate discovered in allergenic extracts, which was similar to the previous year (FY07-93%)
• Blood Derivative manufacturers submitted 10 fewer reports (FY07-59).
  • There were nine reports submitted in FY07 related to an incorrect or missing product label, but no reports were submitted in FY08
  • The number of reports related to the product not meeting specifications, specifically for appearance decreased (FY07-7, FY08-3)
  • The number of reports related to a failure in stability testing remained the same (FY07-14, FY08-14)
• In Vitro Diagnostic manufacturers submitted nine more reports (FY07-69)
  • The number of reports involving incorrect or missing lot number increased (FY07-2, FY08-7)
  • The number of reports related to equipment not performing properly decreased (FY07-10, FY08-4)
  • The number of reports related to the product not meeting specifications increased(FY07-8, FY08-15)
  • The number of reports related to a stability testing performed incorrectly, not performed or not documented decreased (FY07-12, FY08-3)
• Vaccine manufacturers submitted 37 more reports (FY07-60)
  • The number of reports related to broken or cracked vials increased (FY07-6, FY08-18)
  • The number of reports related to the product not meeting specifications increased (FY07-14, FY08-32), specifically, the number reports related to specification for appearance not met, increased (FY07-2, FY08-10)
• There were six more reports identified as potential recall situations (FY07-11)
• There were a number of reports submitted that did not meet the reporting criteria:
  • The product affected by the deviation was not a licensed product
  • There were no products distributed
  • The product was labeled with a shortened expiration date
  • A subsequent stability failure (e.g. at 12 months) was reported after the initial stability failure (e.g. at 6 months) was reported

Total BPD Reports By Manufacturing System

Table 28

Potential Recalls By Manufacturing System

Table 29

 A. Timeliness of BPD Reports

NON-BLOOD MANUFACTURES

Adherence To 45 Day Required Time For Reporting (Reporting Time = Date of FDA receipt – Date of discovery of BPD)

Table 30

*Reporting time = 0 - reports were submitted electronically on the day discovered.

This chart shows the reporting time and the number of total Biological Product Deviation Reports submitted by Non- Blood Manufacturers. Allergenic manufacturers submitted 163 reports within 45 days of discovery, 5 reports between 45 and 90 days, and 1 report greater than 90 days. Derivative manufacturers submitted 43 reports within 45 days of discovery, and 5 reports between 45 and 90 days. In-Vitro Diagnostics manufacturers submitted 60 reports within 45 days of discovery, 10 reports between 45 and 90 days, and 8 reports greater than 90 days. Vaccine manufacturers submitted 58 reports within 45 days of discovery, 28 reports between 45 and 90 days, and 11 reports greater than 90 days. Total number of reports - 393; Allergenic = 169; Derivative = 49; In-Vitro Diagnostics = 78; Vaccines = 97

This chart shows the reporting time and the number of total Biological Product Deviation Reports identified as potential recall situations submitted by Non- Blood Manufacturers. Allergenic manufacturers submitted 2 reports within 45 days of discovery. Derivative manufacturers submitted 7 reports within 45 days of discovery. In-Vitro Diagnostics manufacturers submitted 7 reports within 45 days of discovery. Vaccine manufacturers submitted 1 report within 45 days of discovery. Total number of reports identified as potential recall situations - 17; Allergenic = 2; Derivative = 7; In-Vitro Diagnostics = 7; Vaccines = 1