• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

IV. HCT/P Deviation Reports Submitted by Manufacturers of 361 HCT/Ps

 

The deviation reporting requirement for HCT/Ps regulated under section 361 of the PHS Act became effective on May 25, 2005. Cellular HCT/Ps includes hematopoietic stem/progenitor cells derived from peripheral and cord blood . Tissue HCT/Ps includes all other HCT/Ps, such as bone, skin, cornea, etc.

  • Cellular HCT/Ps:
    • 47 reports involving processing and process controls were reports of contamination or potential contamination during processing
    • There was a decrease from the previous year, in the number of reports involving donor testing (FY08-42, FY07-50), specifically related to Nucleic Acid Testing (NAT) for viral markers performed on pooled samples rather than the required individual sample (testing performed prior to approval of kits for pooled sample testing) {FY08-6, FY07-35}
    • 32 reports involving r eceipt, pre-distribution, shipment & distribution, involved inappropriate distribution of product that was contaminated or potentially contaminated
  • Tissue HCT/Ps:
    • 31 reports involving donor eligibility submitted by tissue manufacturers involved the acceptance of ineligible donors. 17 reports involved risk factors, clinical or physical evidence identified, 10 reports involved incorrectly evaluating donor for plasma dilution and four reports involved donor testing reactive for a relevant communicable disease.
    • 17 reports involving processing and process controls were reports of contamination or potential contamination during processing.
    • 13 reports involving donor screening were reports of the donor medical history interview performed incorrectly.
  • There were a number of reports submitted that did not meet the reporting criteria:
    • The event was not under the control of the reporting establishment
    • There were no products distributed
    • The HCT/P deviation affected a product regulated under section 351 of the PHS Act (e.g., hematopoietic stem/progenitor cells collected from an unrelated allogeneic donor)
    • The event was not associate with core GTPs (e.g., product not shipped at appropriate temperature)
    • The event was not related the prevention of communicable disease transmission or HCT/P contamination (e.g., donor had history of cancer)

Total Reports By Manufacturing System

Table 31

 HCT/P Deviation CodeCellular HCT/PTissue HCT/P

Total

Processing and Processing Controls

50

18

68

30.6%

Donor Testing

42

12

54

24.3%

Donor Eligibility

4

32

36

16.2%

Receipt, Pre-Distribution, Shipment & Distribution

33

3

36

16.2%

Donor Screening

2

15

17

7.7%

Recovery

8

0

8

3.6%

Labeling Controls

0

2

2

0.9%

Supplies and Reagents

1

0

1

0.5%

Environmental Control

0

0

0

0%

Storage

0

0

0

0%

Total

140

82

222

100%

Potential Recalls By Manufacturing System

Table 32

 HCT/P Deviation CodeCellular HCT/PTissue HCT/P

Total

Donor Eligibility

1

22

23

57.5%

Donor Testing

1

8

9

22.5%

Donor Screening

0

3

3

7.5%

Processing and Processing Controls

0

2

2

5.0%

Labeling Controls

0

2

2

5.0%

Receipt, Pre-Distribution, Shipment & Distribution

0

1

1

2.5%

Environmental Control

0

0

0

0%

Supplies and Reagents

0

0

0

0%

Recovery

0

0

0

0%

Storage

0

0

0

0%

Total

2

38

40

100%


A. Timeliness of BPD Reports

361 HCT/P MANUFACTURES

Adherence To 45 Day Required Time For Reporting

(Reporting Time = Date of FDA receipt – Date of discovery of BPD)

Table 33

Reporting Time (days)

Cellular

Tissue

Total

< or = 45

107

76%

54

66%

161

73%

> 45 and <=90

20

14%

18

22%

38

17%

> 90

13

9%

10

12%

23

10%

Total

140

100%

82

100%

222

100%

*Reporting time=0

0

 

1

 

1

 

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

 

This chart shows the reporting time and the number of total HCT/P Deviation Reports submitted by361 HCT/P Manufacturers. Celluar HCT/P manufacturers submitted 107 reports within 45 days of discovery, 20 reports between 45 and 90 days, and 13 reports greater than 90 days. Tissue manufacturers submitted 54 reports within 45 days of discovery, 18 reports between 45 and 90 days, and 10 reports greater than 90 days. Total number of reports - 222; Cellular = 140; Tissue = 82


 

HCT/P Deviation Reports 361 HCT/P Manufacturers Reporting Time - Total Reports

This chart shows the reporting time and the number of total HCT/P Deviation Reports identified as potential recall situations submitted by361 HCT/P Manufacturers. Celluar HCT/P manufacturers submitted 2 reports within 45 days of discovery. Tissue manufacturers submitted 31 reports within 45 days of discovery, 3 reports between 45 and 90 days, and 4 reports greater than 90 days. Total number of reports - 40; Cellular = 2; Tissue = 38

HCT/P Deviation Reports 361 HCT/P Manufacturers Reporting Time - Potential Recalls