FDA Enforcement Report
...REASON Stability test assay failure. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III.....REASON Stability test dissolution failure. _______________ PRODUCT Nitrostat.....REASON Stability test release rate failure. _______________ PRODUCT Beta-HC 1/4% Topical..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00452.html (score=100)

CBER - Recall of Coagulation Factor IX (Human), AlphaNine SD
...The manufacturer found failed stability test results for Factor IX activity during storage at 30..
http://www.fda.gov/cber/recalls/alpcfix021903.htm (score=100)

HUMAN DRUG CGMP NOTES December, 1996
...However, because the technology may not have been available, older applications lacking.....Concern about the potential health effects to people working with DOP test aerosols has.....Absent documentation that the methods are stability indicating, districts should contact..
http://www.fda.gov/cder/hdn/cnotesd6.htm (score=77)

Untitled Document
...Regarding your investigation of the Mumps Vaccine stability test failures, it did not include.....Regarding the Mumps Virus Vaccine Live stability data, your response indicated the stability profile of each lot was within the.....Failure to describe in an annual report any changes in the production process or test i..
http://www.fda.gov/foi/warning_letters/g4238d.htm (score=55)

116 Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance
...The value of accelerated stability test data relies on identical decomposition mechanisms at both.....Stability studies should monitor the critical parameters of a device that are required to.....loss of sterility at 25ºC versus protein denaturation at 50ºC), accelerated stability test data..
http://www.fda.gov/cdrh/ode/116.html (score=54)

Premarket Approval Decisions for July 2000
...stability test. P950035/S006.. 7/5/00.. 180-Day.. NeuroControl Freehand™ System..
http://www.fda.gov/cdrh/pma/pmajul00.html (score=54)

HUMAN DRUG CGMP NOTES September 1998
...To ensure that stability testing is performed at the assigned test intervals in an approved stability testing protocol.....Similarly, if stability testing that is supposed to be performed prior to the end of the.....You may find this helpful to expand your knowledge of CGMPs and simultaneously test and..
http://www.fda.gov/cder/hdn/cnotes98.htm (score=32)

HUMAN DRUG CGMP NOTES September 1996
...Failing to submit annual reports or excluding specific lots from the stability program in.....Excluding from the submission, in-process test records which show the product fails to.....Inaccurate/untrue information relative to the production of the bio-batch or stability..
http://www.fda.gov/cder/hdn/hdn996.htm (score=32)

HUMAN DRUG CGMP NOTES March 1999
...For example, if the protocol deviation was well documented by the firm in both its stability test.....Should investigators cite firms for not conducting accelerated stability testing during.....That would put the responsible firm in a position of having to test each and every lot of..
http://www.fda.gov/cder/hdn/cnotes39.htm (score=32)

BIOTECHNOLOGY INSPECTION GUIDE
...Various forms of the LAL test include a gel clot test, a colormetric test, a chromogenic test, and a turbidimetric.....Because genetic stability of the cell bank during storage and propagation is a major.....The LAL test is easier, quicker, less costly and much more sensitive that the rabbit test..
http://www.fda.gov/ora/inspect_ref/igs/biotech.html (score=32)

ABC Compounding Company, Inc. Warning Letter
...The three year stability test results for HAND AID Instant Hand Sanitizer indicate that it fails to.....While this singular lot provides positive information regarding the product s stability, earlier stability.....You have failed to establish an adequate stability testing program to determine..
http://www.fda.gov/foi/warning_letters/g5091d.htm (score=32)

GUIDE 1 Note: This document is reference materials for investigators...
...They may accept stability test results showing an apparent increase in the assay of the drug with.....If there is no stability-indicating assay additional assay procedures such as TLC should.....Most manufacturers use systems that provide for the investigation of laboratory test..
http://www.fda.gov/ora/inspect_ref/igs/pharm.html (score=32)

Preparing Data for Electronic Submission in ANDAs
...For executed batches, the stability forms should describe the stability testing that was done on these batches in support of.....The comments box should explain that this single test form refers to multiple test.....For blank batch descriptions, the stability forms should describe the proposed stability studies for manufacturing batches that are the..
http://www.fda.gov/cder/guidance/3223fnl.htm (score=32)

QA Letter
...Any changes to an approved stability protocol should have a supplemental approval prior to.....The supplement should contain a commitment to use the same SOP's and test methods employed.....Batches should be tested annually as per the stability commitments in the approved..
http://www.fda.gov/cder/guidance/qaletter.htm (score=32)

Guidance for Industry: Changes to an Approved Application for Specified...
...Modifications in analytical procedures with no change in the basic test methodology or.....alters the acceptance criteria of the stability protocol. Scale-up requiring a larger.....Establishment of an alternate test method for reference standards, release panels, or..
http://www.fda.gov/cber/gdlns/chbiosyn.htm (score=31)

SUPAC
...One batch with three months accelerated stability data and one batch on long-term.....The 90% confidence intervals for the estimates of the difference between the test and.....1 batch with 3 months accelerated stability data in supplement and 1 batch on long-term..
http://www.fda.gov/cder/guidance/supac.htm (score=31)

C:\WPFILES\GUIDANCE\CHEMISTR\CMC5.
...1 batch with 3 months accelerated stability..data in supplement and 1 batch on long-term.....for the estimates of the difference between the test and reference least..squares means.....over a short period of time, or where the number of batches needed for stability..testing..
http://www.fda.gov/cder/guidance/cmc5.pdf (score=31)

ENFORCEMENT REPORT FOR APRIL 28, 1999
...REASON Microbial contamination - Product failed specification for microbial limits test at 12 month stability test.....test equipment, odor testing, and production records. ________ PRODUCT Trichloroacetic..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00587.html (score=31)

FDA Enforcement Report For 02/04/98
...REASON Subpotent (12 month stability test point). _______________ PRODUCT Polymyxin B Sulfate, USP..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00523.html (score=31)

FDA Enforcement Report For November 4, 1998
...Products failed routine stability testing. #### End of Enforcement Report for November 4.....Subpotent (18 month stability test station). RECALLS AND FIELD CORRECTIONS: BIOLOGICS..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00562.html (score=31)

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