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Forest Laboratories Inc. Message Board

  • bunkerblaster2003 bunkerblaster2003 Aug 19, 2003 10:26 AM Flag

    U.S. FDA warns Forest on thyroid drug

    U.S. FDA warns Forest on thyroid drug marketing

    August 19, 2003 08:42:58 (ET)


    WASHINGTON, Aug 19 (Reuters) - The U.S. Food and Drug Administration has sent a warning to Forest Laboratories Inc. (FRX,Trade) for failing to obtain approval for thyroid drug Levothroid and ordered that production be phased out, according to a letter released Tuesday.

    "You have failed to obtain an approved application and have made a deliberate decision not to follow the agency's gradual phase-out plan ...," the FDA wrote in a letter dated Aug. 7.

    The letter

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    • Now, how do we trust these SOBs when they do these in thier factory?

      Foreign pills found on 12 occations on their assembly line?

      If FRX tanks tomorrow, I will surely join class action suit.

      It hurts my conscience so bad, that I think I will be a seller in A.M. with deep losses.

    • <<Drug product release specifications are not appropriate to assure drug products will meet specifications throughout their shelf life. Levothroid� (levothyroxine sodium tablets, USP) can be released with assays as low as [redacted] even though your stability data show potency drops of 11-16% in some samples before the expiration period. If these lots were released at [redacted] potency, they would fall below the 90% USP lower limit for levothyroxine sodium tablets, USP during their shelf life.>>

      WTFIT?

    • <<When a unit dose sample fails a leak test, only part of the batch produced since the last acceptable leak test is quarantined and sampled as part of the failure investigation. Eight separate instances were observed where the unit does samples failed the leak testing and those portions were destroyed, yet no further portions of the sampled lots or prior lots were examined.
      5. Packaging facilities are not inspected immediately before use to assure all drug products have been removed>>

      WTFIT?

    • <<Since January 1, 2001 there have been 14 instances where foreign tablets were found during packaging on line 2>>

      WTFIT?

    • Wow, this is ugly. I have just been reviewing articles, speaking to distributors, and reps.
      From my understanding, this thing spreads from tampering with tests to just plain trying to hide crappy manufacturing practices.

      I could not get any clear information if Forest has intent to straighten up, make things right with the FDA, and continue to sell the Thryoid drugs in the distant future or not. It is a really bad sign of how management has played this out. With huge growth potential of elderly on thryoid meds, 1 and 10 women currently, and 1 in 20 men, what are the are they thinking?

      • 1 Reply to s_n_p_sucks
      • "From my understanding, this thing spreads from tampering with tests to just plain trying to hide crappy manufacturing practices."

        "Tampering with tests ?!!! What more did they tell you? Could this include their recent "findings" on neuropathic pain and Memantine??? I had believed that Forest had a management to be trusted and that their drug applications were so tight that they ALL sailed successfully through the FDA approval process without making waves.

        Then Forest announced the "failure" of Memantine in neuropathic pain, without warning, an hour or so before NTII's last conference call, leaving everyone stunned about the motives behind their timing.

        This thread on the NTII board seems even more telling under the dark shadow that has fallen over FRX management today.

        http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600934110&tid=ntii&
        sid=1600934110&mid=7334

    • you know what? That's a disgraceful letter for a company like FRX to get. Their VP of Regulatory Affairs or QA/QC should be fired immediately.

    • than one thyroid drug.

      EXCERPTS:

      "This letter is in reference to the inspection of your finished pharmaceutical manufacturing plant...conducted on January 28 - February 20, 2003.

      ...During this same inspection, our investigators also documented deviations from current Good Manufacturing Practice for drug products set forth in Title 21, Code of Federal Regulations

      ...Your firm lacks adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess

      ...Acceptance criteria for the sampling and testing conducted by the quality control unit are not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release

      ...Results of stability testing are not used in determining appropriate storage conditions and expiration dates.

      ...Acceptance criteria for the sampling and testing conducted by the quality control unit are not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.

      ...Packaging facilities are not inspected immediately before use to assure all drug products have been removed from previous operations...Since January 1, 2001 there have been 14 instances where foreign tablets were found during packaging on line 2

      ...This letter is not intended to be an all-inclusive list of deficiencies at your facility...It is your responsibility to assure that all products distributed by your firm meet the requirements of the Act and its implementing regulations.

      ...We request that you notify this office in writing within 15 working days of receipt of this letter stating the action you will take to ...bring your other drug products into compliance."

    • non event for FRX.

      All eyes are on Memantine and extended approval for Lexapro.

      expect moderate run up anticipating these events this Q.

    • Although not cited on the FDA-483, it was determined that stability samples for Levothroid� are not stored under appropriate conditions. Your records indicate these samples were moved from ambient relative humidity conditions at 25��2�C to 60%�5% relative humidity at the same temperature for a period of approximately 8 months. Stability testing showed at least one unit dose packaging system was failing potency before its expiration date. You then returned the product to what you described as ambient humidity conditions. However, our investigators observed that the room that was designated as having ambient humidity was not being maintained at ambient humidity. On 1/28/03 our investigators observed a dehumidifier in the room and the humidity chart showed levels below 15%. Stability results based on such artificially reduced humidity conditions are not appropriate to assure valid estimates of stability.
      4. Acceptance criteria for the sampling and testing conducted by the quality control unit are not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release. 21 CFR 211.165(d)

      When a unit dose sample fails a leak test, only part of the batch produced since the last acceptable leak test is quarantined and sampled as part of the failure investigation. Eight separate instances were observed where the unit does samples failed the leak testing and those portions were destroyed, yet no further portions of the sampled lots or prior lots were examined.
      5. Packaging facilities are not inspected immediately before use to assure all drug products have been removed from previous operations. 21 CFR 211.130(e)

      Since January 1, 2001 there have been 14 instances where foreign tablets were found during packaging on line 2.
      We received a letter from Karl Fricke, Ph.D., Director of QC/QA, and Gregory Yurchak, Plant Manager, dated March 19, 2003, which was in response to the observations listed on the Form FDA-483 issued at the close of the inspection. The corrective actions offered in Mr. Fricke�s response were taken into account in preparing this letter.

      This letter is not intended to be an all-inclusive list of deficiencies at your facility. A copy of the Form FDA-483 is enclosed for your information. It is your responsibility to assure that all products distributed by your firm meet the requirements of the Act and its implementing regulations.

      We request that you notify this office in writing within 15 working days of receipt of this letter stating the action you will take to discontinue the marketing of your Levothroid� (levothyroxine sodium tablets, USP) drug products and to bring your other drug products into compliance. Your reply should include an estimate of the amount of Levothroid� that is in inventory under your control. Failure to achieve prompt correction may result in regulatory action without further notice. The Act provides for seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products.

      Your reply should be sent to the attention of Charles S. Price, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. Any questions regarding this letter may be directed to Mr. Price at telephone (513) 679-2700 extension 165.

      Sincerely,
      /s/
      Deborah Grelle
      for Carol A. Heppe
      District Director
      Cincinnati District

    • 2. Your firm lacks adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. 21 CFR 211.100(a)


      Your firm lacks written procedures for temperature and moisture controls for in-process materials that are sensitive to heat and moisture.

      Process validation of the Thyrolar� (liotrix tablets, USP) was considered successful even though the lot failed to meet individual blend uniformity specifications and was eventually recalled due to super potent stability assay results. The validity of this process also comes into question because several other lots of this product were either rejected due to super potency or found super potent upon original analyses but accepted based upon retest results. These original results were voided and the retest results accepted without justification.
      3. Results of stability testing are not used in determining appropriate storage conditions and expiration dates. 21 CFR 211.166(a)...

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