AVA Stockpile Analysis-Supplemental Testing Needed and/or Resolvable FDA Issues
November 13, 1998
|
LOT |
Inventory |
Cumulative Inventory |
Expiration Date |
FDA HOLD |
SUPP TESTING |
|
FAVO09 |
63840 |
63840 |
30-Aug-97 |
NONE |
POTENCY |
|
FAV010 |
204870 |
268710 |
11-Oct-97 |
NONE |
POTENCY |
|
FAV013 |
206610 |
475320 |
22-Nov-97 |
NONE |
POTENCY, PHEMEROL |
|
FAY014 |
214100 |
689420 |
25-Jul-98 |
NONE |
PHEMEROL |
|
FAV015 |
210050 |
899470 |
29-Sep-98 |
NONE |
PHEMEROL |
|
FAV015 |
135730 |
1035200 |
11-Jun-99 |
PARTICULATES |
PHEMEROL |
|
FAV018 |
189810 |
1225010 |
11-Jun-99 |
POTENCY |
POTENCY |
|
FAV021 |
214600 |
1439510 |
28-Jan-00 |
POTENCY |
NONE |
|
FAV022 |
193970 |
1633580 |
15-Oct-99 |
POTENCY |
POTENCY |
|
FAV023 |
203030 |
1836610 |
29-Mar-97 |
POTENCY |
POTENCY |
|
FAV024 |
208880 |
2045490 |
11-Apr-00 |
NONE |
POTENCY |
|
FAV025 |
214810 |
2260300 |
24-May-97 |
POTENCY |
POTENCY |
|
FAV028 |
177720 |
2438020 |
27-Aug-99 |
POTENCY |
POTENCY |
|
FAV029 |
197790 |
2635810 |
9-Jul-99 |
STERILITY ASSURANCE |
POTENCY |
|
FAV031 |
189700 |
2825510 |
6-0ct-97 |
NONE |
NONE |
|
FAV032 |
201090 |
3026600 |
6-Oct-98 |
STERILITY ASSURANCE |
POTENCY |
|
FAV035 |
202500 |
3229100 |
28-Jan-00 |
STERILITY ASSURANCE |
POTENCY |
|
FAV037 |
207650 |
3436750 |
25-Feb-00 |
NONE |
POTENCY |
|
FAV039 |
189190 |
3625940 |
25-Feb-00 |
NONE |
POTENCY |
Note 1) For expired lots, FDA must accept a longer dating period or extension of dating; needs regulatory submission.
Note 2) Entries of "POTENCY'' require mom testing and/or approval of pending supplement for method of calculation of potency.
Note 3) Entries of "Phemerol" require an FDA approval of a yet to be submitted request for a change in the Phemerol specification.
Note 4) Anticipate approvals by May, 1999, but there are no guarantees that FDA will approve.