Biological Product Deviation Reports
Annual Summary for Fiscal Year 2005
Attachment 3: Number of BPD Reports by Type of Non-Blood Manufacturer
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| BPD CODES | Allergenic | Derivative | In-Vitro Diagnostic | Vaccine | TOTAL | |
|---|---|---|---|---|---|---|
| Incoming Material | 14 | 3.65% | ||||
| IM1301 | 0 | 2 | 0 | 1 | 3 | 0.78% |
| IM1302 | 0 | 1 | 0 | 0 | 1 | 0.26% |
| IM1401 | 0 | 5 | 3 | 0 | 8 | 2.08% |
| IM1405 | 0 | 1 | 0 | 0 | 1 | 0.26% |
| IM1406 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| Labeling | 73 | 19.01% | ||||
| LA4001 | 0 | 1 | 5 | 0 | 6 | 1.56% |
| LA4101 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| LA4102 | 0 | 0 | 1 | 2 | 3 | 0.78% |
| LA4201 | 1 | 1 | 4 | 0 | 6 | 1.56% |
| LA4202 | 0 | 5 | 0 | 9 | 14 | 3.65% |
| LA4302 | 0 | 4 | 0 | 0 | 4 | 1.04% |
| LA4401 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| LA4402 | 18 | 1 | 2 | 0 | 21 | 5.47% |
| LA4501 | 0 | 0 | 0 | 1 | 1 | 0.26% |
| LA4502 | 0 | 2 | 9 | 0 | 11 | 2.86% |
| LA4801 | 3 | 1 | 1 | 0 | 5 | 1.30% |
| Process Controls | 28 | 7.29% | ||||
| PC2001 | 0 | 1 | 0 | 1 | 2 | 0.52% |
| PC2103 | 1 | 0 | 0 | 0 | 1 | 0.26% |
| PC2104 | 0 | 0 | 0 | 1 | 1 | 0.26% |
| PC2201 | 0 | 1 | 1 | 1 | 3 | 0.78% |
| PC2203 | 0 | 0 | 1 | 1 | 0.26% | |
| PC2204 | 0 | 1 | 14 | 1 | 16 | 4.17% |
| PC2205 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| PC2206 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| PC2401 | 0 | 2 | 0 | 0 | 2 | 0.52% |
| Product Specifications | 235 | 61.20% | ||||
| PS5001 | 0 | 0 | 4 | 0 | 4 | 1.04% |
| PS5101 | 0 | 0 | 7 | 0 | 7 | 1.82% |
| PS5102 | 166 | 0 | 0 | 0 | 166 | 43.23% |
| PS5108 | 1 | 1 | 2 | 1 | 5 | 1.30% |
| PS5109 | 0 | 0 | 3 | 1 | 4 | 1.04% |
| PS5110 | 0 | 0 | 4 | 0 | 4 | 1.04% |
| PS5201 | 0 | 2 | 0 | 2 | 4 | 1.04% |
| PS5301 | 0 | 2 | 2 | 1 | 5 | 1.30% |
| PS5302 | 10 | 3 | 8 | 8 | 29 | 7.55% |
| PS5304 | 0 | 0 | 0 | 1 | 1 | 0.26% |
| PS5305 | 0 | 3 | 0 | 2 | 5 | 1.30% |
| PS5306 | 0 | 0 | 0 | 1 | 1 | 0.26% |
| Quality Control & Distribution | 13 | 3.39% | ||||
| QC6101 | 0 | 0 | 2 | 0 | 2 | 0.52% |
| QC6102 | 0 | 0 | 0 | 1 | 1 | 0.26% |
| QC6103 | 0 | 0 | 0 | 1 | 1 | 0.26% |
| QC6104 | 0 | 2 | 0 | 0 | 2 | 0.52% |
| QC6105 | 0 | 1 | 0 | 0 | 1 | 0.26% |
| QC6202 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| QC6401 | 0 | 1 | 1 | 0 | 2 | 0.52% |
| QC6402 | 0 | 0 | 1 | 0 | 1 | 0.26% |
| QC6403 | 0 | 0 | 2 | 0 | 2 | 0.52% |
| Testing | 21 | 5.47% | ||||
| TE3001 | 0 | 0 | 8 | 0 | 8 | 2.08% |
| TE3301 | 0 | 1 | 2 | 0 | 3 | 0.78% |
| TE3401 | 0 | 2 | 0 | 0 | 2 | 0.52% |
| TE3601 | 0 | 0 | 4 | 0 | 4 | 1.04% |
| TE3602 | 0 | 0 | 3 | 1 | 4 | 1.04% |
| TOTAL | 200 | 47 | 100 | 37 | 384 | 100% |