• An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has...
    22 KB (2,824 words) - 00:39, 7 November 2024
  • in March 2018. In 2019, Aid Access received a warning letter from the Food and Drug Administration (FDA) stating that they were not authorized to distribute...
    24 KB (2,629 words) - 16:38, 14 November 2024
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    including headache, fatigue, and dizziness. In August 2008, the FDA issued a Warning Letter to Forest Laboratories citing exaggerated and misleading claims...
    25 KB (2,499 words) - 04:49, 27 October 2024
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    Retrieved February 14, 2015. Correll Jr WA (February 5, 2019). "FDA Warning Letter: Peak Nootropics LLC aka Advanced Nootropics". Office of Compliance...
    32 KB (3,198 words) - 10:20, 19 November 2024
  • Thumbnail for Taro Pharmaceuticals
    2024. In February 2009, the US Food and Drug Administration (FDA) released a warning letter to Taro Pharmaceuticals pointing out some issues relating to...
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    "FDA Warning Letter: Optimal Wellness Center, 16 February 2005". US Food and Drug Administration. Archived from the original on August 29, 2016. "FDA Warning...
    50 KB (4,532 words) - 14:10, 3 November 2024
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    Retrieved 11 May 2019. William A Correll, Jr. (5 February 2019). "FDA Warning Letter: Peak Nootropics LLC aka Advanced Nootropics". Office of Compliance...
    11 KB (949 words) - 23:15, 14 December 2024
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    jlindasmith (2020-05-05). "WARNING LETTER [PDF]". Presentica. Retrieved 2022-09-21. kreidler, Marc (2019-03-27). "FDA Warning Letter to Swanson Health Products...
    6 KB (601 words) - 08:45, 8 September 2024
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    Administration sent an FDA warning letter to Jimmy John's detailing evidence from five outbreaks of human infections with Escherichia coli. The letter said that the...
    33 KB (3,070 words) - 02:14, 1 December 2024
  • capability, but currently under FDA warning letter Oncology injectable facility at Hinjawadi, but currently under FDA warning letter Solid Orals facilities at...
    13 KB (1,032 words) - 06:05, 17 December 2024
  • US FDA. "Warning Letter" FLA-99-29 US FDA. "Warning Letter" UCM075960 – Accessed 4 February 2010 US FDA. "Warning Letter" UCM066113 US FDA. "Warning Letter"...
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    marketed to contain an adaptogen. As an example in 2020, the FDA issued a warning letter to a manufacturer of mushroom supplements purported to contain...
    6 KB (553 words) - 02:19, 8 October 2024
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    consumers. Since 2007, the US Food and Drug Administration (FDA) has issued dozens of warning letters to manufacturers of skin care products with false...
    5 KB (541 words) - 00:14, 30 November 2024
  • gets FDA warning letter for Ireland plant". Reuters. Retrieved 15 October 2008. Ellsworth, Douglas (28 November 2007). ""Warning Letter." Letter to Steven...
    34 KB (3,443 words) - 16:57, 10 November 2024
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    Chocolate)". Nutraceuticals World. Rodman Media. Retrieved 13 April 2013. "FDA warning letter to Let's Talk Health, Inc". US Food and Drug Administration, Division...
    27 KB (2,503 words) - 06:48, 25 November 2024
  • York Times. Retrieved 2008-03-20. "Warning Letter: Changzhou SPL Company, Ltd (a/k/a "Kaipu")". FDA Warning letter. FDA. Retrieved 28 July 2010. Harris,...
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    referred to as "Wock", short for Wockhardt. Wockhardt received a FDA warning letter 25 November 2013 identifying significant violations of current good...
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  • conditions. In 2017, LifeVantage was issued a warning letter by the U.S. Food and Drug Administration (FDA) regarding illegal advertising claims on the...
    27 KB (2,659 words) - 14:37, 2 September 2024
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    December 2016. Retrieved 7 March 2018. Tave SJ (26 February 2018). "FDA warning letter to Industrial Chemicals, LLC, and INI Botanicals" (PDF). Office of...
    81 KB (8,712 words) - 20:53, 9 December 2024
  • Zicam Cold Remedy. The FDA also issued a Warning Letter to Matrixx, stating that the products cannot be marketed without FDA approval. The company initially...
    15 KB (1,661 words) - 06:50, 13 October 2024
  • Administration (FDA) reviewed the Velvetines Liquid Matte Lipsticks and issued an official warning letter for the shade “red velvet.” This letter stated that...
    22 KB (2,481 words) - 16:21, 26 August 2024
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    23andMe (section FDA)
    purchased the test from November 22, 2013, in order to comply with the FDA warning letter, while undergoing regulatory review. In May 2014, it was reported...
    72 KB (6,848 words) - 18:24, 30 November 2024
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    (5 February 2019). "Peak Nootropics LLC aka Advanced Nootropics". FDA Warning letter. U.S. Food and Drug Administration. Cohen PA, Avula B, Wang YH, Zakharevich...
    12 KB (1,028 words) - 03:25, 22 December 2024
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    Retrieved 2008-09-22. "FDA Warning Letter" (PDF). U.S. Food and Drug Administration. 2001-03-13. Retrieved 2008-09-22. "FDA Warning Letter". U.S. Food and Drug...
    56 KB (5,945 words) - 02:07, 4 December 2024
  • control over the CDMO's compliance for the client, for example when an FDA warning letter is issued, a resulting interruption of production may result in major...
    15 KB (1,428 words) - 09:28, 2 December 2024
  • Thumbnail for Morinda citrifolia
    manufacturer of food and skincare products based on this fruit was issued an FDA warning letter for marketing unapproved drugs and making false health claims in violation...
    21 KB (2,039 words) - 09:19, 18 December 2024
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    2017. Retrieved 30 April 2017. Wagner, Roberta (22 February 2010). "FDA Warning Letter to Diamond Food, Inc". US Food and Drug Administration, Inspections...
    31 KB (2,999 words) - 18:30, 20 November 2024
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    2019, Inova stopped pharmacogenomic testing after receiving a warning letter from the FDA. "Inova names its new CEO" (PDF). www.bizjournals.com. March...
    18 KB (1,599 words) - 23:40, 4 December 2024
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    similar terms, and for the relabeling of some products. After an FDA Warning Letter protesting Kraft's use of MPC in late 2002, some varieties of Kraft...
    20 KB (2,296 words) - 02:45, 8 October 2024
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    of commercial 4-AT. In a FDA Warning Letter[citation needed] dated July 7, 2006, the U.S. Food and Drug Administration (FDA) argues that marketing of...
    8 KB (755 words) - 12:08, 25 March 2024