ML20133L675
| ML20133L675 | |
| Person / Time | |
|---|---|
| Site: | 07000036 |
| Issue date: | 11/13/1970 |
| From: | Schottelkorb F MALLINCKRODT, INC. |
| To: | Cunningham E US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20133G976 | List:
|
| References | |
| FOIA-96-343 NUDOCS 9701220102 | |
| Download: ML20133L675 (3) | |
Text
8 O
b ee B o x 10172 L A M B E R ( FI E L D e ST. LOUIS, MIS $ouRI 6 314 5 e 314 A X 1 0 5 4 0 NUCLE AR November 13, 1970 Mr. R. E. Cunningnam Assistant Director for Plans and Technical Programs Division of Materials Licensing United States Atomic Energy Commission Washington, D. C.
20545
Dear Mr. Cunningham:
This is in further reference to the Mallinckrodt shipment on September 7 of "Neimotec Sterile Generators" from Carlstadt, New Jersey. We have developed protocols and procedures for corporate and customer notification, and product recall, which, we believe, will eliminate the possibility of a recurrence.
We have further strengthened our Quality Control procedures as follows:
at each production site a Quality Control technician will immediately notify the Quality Control Supervisor of data outside specifications. Upon notification from the technician, as above, or upon routine completion of Quality Control tests, the Quality Control Supervisor will immediately review the data.
If the data are within specifications, he will release the batch for shipment or use.
If not within specifications, he will notify the Manager of Quality Control or his designated representative.
The Manager of Quality Control will immediately notify the Director of Radiopharmaceutical Operations, or his designated representative, who will decide whether to initiate recall procedures. If recall procedures are initiated, the Director of Radiopharmaceutical Operations, or his designated representative will immediately initiate (a.) Customer notification; (b.)
Product withdrawal; (c.) Notifi-cation of concerned governmental regulatory agencies; (d.) Notifica-tion of concerned corporate departments (Quality Control, Research and Development).
9701220102 970114 PDR FOIA FLOYD96-343 PDR
/M ALLIN CKRooT CHE MIC AL WOR KS
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,Therefore, no deviation in manufacturing practices, such as generator manufacture seven days prior to calibration rather than five days, nor allowance for shipment of material not meeting l
Quality Control specifications, will be permitted.
Thank you for your consideration of these matters. We look forward to your reply.
^
j Sincerely, j
j i
Frank A. Schottelkorb General Manager d
Diagnostics Products Division J
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