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FDA – Warning Letter

April 14, 2020February 6, 2024 Pharmaceutical Guidanace

FDA – Warning Letter September 10, 2019

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Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.

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FDA – Warning Letter

USFDA WARNING LETTER Aberdeen, Aberdeenshire, Abu Dhabi, Abu Dhalouf, Abu Hamour, Abu Samra, ABUJA, ACCRA, Acre, Ad Dawhah al Jadidah, ADDIS ABABA, Adelaide, AFGHANISTAN, Agra, Agrigento, Ahmedabad, Aïn Beïda, Ain Khaled, Ain Sinan, Ajman, Ajman and Ra’s al-Khaimah, Ajmer, Al Ain, Al Aziziya, Al Bidda, Al Daayen, Al Dafna, Al Ebb, Al Egla, Al Gharrafa, Al Ghuwariyah, Al Hilal, Al Jasrah, Al Jeryan, Al Karaana, Al Kharaitiyat, Al Kharayej, Al Kharrara, Al Kheesa, Al Khor, Al Khulaifat, Al Luqta, Al Mamoura, Al Mansoura, Al Markhiyah, Al Mashaf, Al Masrouhiya, Al Mearad, Al Messila, Al Mirqab, Al Najada, Al Nasraniya, Al Qassar, Al Rufaa, Al Sadd, Al Sailiya, Al Sakhama, Al Seej, Al Shagub, Al Souq, Al Tarfa, Al Thakhira, Al Themaid, Al Thumama (Al Wakrah), Al Thumama (Doha), Al Utouriya, Al Waab, Al Wajba, Al Wakrah, Al Wukair, Al Zubarah, Al-Shahaniya, Alagoas, ALBANIA, Alberta, Alessandria, ALGERIA, Algiers, Aligarh, Allahabad, Allerdale, Amapa, Amazonas, Amber Valley, Amersham, AMMAN, Ampthill, Amravati, Amritsar, Amsterdam, Amur, Ancona, and Craigavon, and Down, ANDORRA, ANDORRA LA VELLA, ANGOLA, Angus, ANKARA, Annaba, ANTANANARIVO, ANTIGUA & BARBUDA, Antrim and Newtownabbey, Antwerp, Aosta, APIA, Ar Ru'ays, Ards and North Down, ARGENTINA, Argyll and Bute, Arkhangelsk, Arlington, Armagh, ARMENIA, As Salatah, Ascoli Piceno, Ashbourne, ASHGABAT, ashington, Ashland, Ashmore and Cartier Islands, ASMARA, Asti, Astrakhan, ASUNCIÓN, Athens, Auckland, Aurangabad, australia, Australian Antarctic Territory, Australian Capital Territory, Austria, Avellino, Aylesbury, Aylesbury Vale, AZERBAIJAN, Baaya, BAGHDAD, BAHAMAS, Bahia, BAHRAIN, BAKU, BAMAKO, Banbridge, BANDAR SERI BEGAWAN, Bangalore, BANGKOK, Bangladesh, Bangor, BANGUI, Bani Hajer, BANJUL, Barahat Al Jufairi, BARBADOS, Barcelona, Bareilly, Bari, Barletta-Andria-Trani, Barrow-in-Furness, BASSETERRE, Bath, Batna, Bavaria, Beaconsfield, Béchar, Bedford, BEIJING, BEIRUT, Béjaïa, Belarus, Belfast, Belgium, Belgorod, Belgrade, BELIZE, Belluno, BELMOPAN, Belper, Benevento, BENIN, Bergamo, Berlin, BERN, Bhavnagar, Bhilai Nagar, Bhiwandi, Bhopal, Bhubaneswar Salem, BHUTAN, Biella, Bikaner, Birmingham, Birmingham (West Midlands), BISHKEK, Biskra, BISSAU, Blackburn with Darwen, Blackpool, Blaenau Gwent, Blida, BLOEMFONTEIN, Bloomsbury, Bodmin, BOGOTÁ, BOLIVIA, Bologna, Bolsover, Bordj Bou Arreridj, BOSNIA & HERZEGOVINA, BOTSWANA, Bou Saâda, Bournemouth, Bracknell Forest, Bradford, BRASILIA, BRATISLAVA, brazil, BRAZZAVILLE, Bremen, Brescia, Bridgend, BRIDGETOWN, Brighton, Brighton and Hove, Brindisi, Brisbane, Bristol, British Columbia, BRUNEI, BRUSSELS, Brussels-Capital Region, Bryansk, Bu Fasseela, Bu Samra, Bu Sidra, Bucharest, Buckinghamshire, Budapest, BUENOS AIRES, BUJUMBURA, Bulgaria, BURKINA FASO, Burlington, BURUNDI, Buxton, CABO VERDE, Caerphilly, Cagliari, CAIRO, Caltanissetta, CAMBODIA, Cambridge, Cambridgeshire, Camden, CAMEROON, Campobasso, canada, Canberra, Canterbury, CAPE TOWN, Cardiff, 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Hobart, HONDURAS, HONIARA, Hove, Hubli and Dharwad, Hudson, Hungary, Huntingdon, Huntingdonshire, hyderabad, ICELAND, Imperia, Indonesia, Indore, Inverclyde, Invergordon, Inverness, Iqaluit, Iran, Iraq, ireland, Irkutsk, Irvine, Isernia, ISLAMABAD, Isle of Anglesey, Isle of Wight, Isles of Scilly, ISRAEL, Istanbul, Italy, Ivanovo, Izghawa (Al Rayyan), Izghawa (Umm Salal), Jabal Thuaileb, Jabalpur, Jackson, Jaipur, JAKARTA, Jalandhar, jamaica, Jammu, Jamnagar, Jamshedpur, japan, Jelaiah, JERUSALEM, Jervis Bay Territory, Jeryan Jenaihat, Jeryan Nejaima, Jhansi, Jijel, Jodhpur, jordan, JUBA, KABUL, Kaliningrad, Kaluga, Kalyan, KAMPALA, Kanpur, KATHMANDU, Katowice urban area, KAZAKHSTAN, Kazan, Kemerovo, Kendal, Kent, KENYA, Keswick, Kharkiv, KHARTOUM, Khawr al Udayd, Kiev, KIGALI, Kingston, Kingston upon Hull, KINGSTOWN, Kinross, KINSHASA, KIRIBATI, Kirkintilloch, Kirkwall, Kirov, Knutsford, Kochi, Kolkata, KOSOVO, Kostroma, Kota, Kraków, KUALA LUMPUR, Kurgan, Kursk, kuwait, KUWAIT CITY, KYRGYZSTAN, L'Aquila, La Spezia, Laghouat, Lancashire, Lancaster, LAOS, Latina, LATVIA, Launceston, Leabaib, Lebanon, Lebday, Lecce, Lecco, Leeds, Leicester, Leicestershire, Lejbailat, Lekhwair, Leningrad, Leqtaifiya (West Bay Lagoon), LESOTHO, Lexington, LIBERIA, LIBREVILLE, LIBYA, Lichfield, LIECHTENSTEIN, Lijmiliya, Lille–Kortrijk–Tournai France/ Belgium, LILONGWE, LIMA, Lincoln, Lincolnshire, Lipetsk, Lisbon, Lisburn, Lisburn and Castlereagh, LITHUANIA, Liverpool, Livorno, LJUBLJANA, LOMÉ, london, Loni, Looe, Lossiemouth, Lostwithiel, Luaib, LUANDA, Lucca, Lucknow, Ludhian, Lusail, LUSAKA, Luton, LUXEMBOURG, M'Sila, Macclesfield, Macerata, MADAGASCAR, Madinat Al Kaaban, Madinat ash Shamal, Madinat Khalifa North, Madinat Khalifa South, Madison, Madrid, Madurai, Magadan Moscow, Maghnia, MAJURO, MALABO, malawi, Malaysia, MALDIVES MALE, MALI, MALTA, MANAGUA, MANAMA, Manchester, MANILA, Manitoba, Mantua, Maranhao, Marlborough, Marlow, Marseille, Mascara, MASERU, Massa and Carrara, Matera, Matlock, Mato Grosso, Mato Grosso do Sul, MAURITANIA, mauritius, MBABANE, Mebaireek, Médéa, Medway, Meerut, Mehairja, Melbourne, Merseyside, Merthyr Tydfil, Mesaieed, Mesaimeer, Messina, Mexico, MEXICO CITY, Mid and East Antrim, Mid Ulster, Middlesbrough, Midlothian, Milan, Milford, Milngavie, Milton, Milton Keynes, Minas Gerais, Minsk, Modena, MOGADISHU, Monmouthshire, MONROVIA, MONTEVIDEO, Monza and Brianza, Moradabad, Moray, MORONI, Moscow, Mostaganem, Motherwell and Wishaw, Mount Vernon, Mourne, Muaither, Mumbai, Muraikh, Murmansk, MUSCAT, Mushayrib, Mysore, N'DJAMENA, Nagpur, NAIROBI, Najma, NAMIBIA WINDHOEK, Nanded Kolapur, Nantwich, Naples, Nashik, NASSAU, NAURU, Navi Mumbai, Neath Port Talbot, Nellore, Nelson, Nepal, Netherlands, New Al Hitmi, New Al Mirqab, New Al Rayyan, New Brunswick, New Fereej Al Ghanim, New Fereej Al Khulaifat, New Plymouth, New Salata, New South Wales, new Zealand, Newfoundland and Labrador, Newport, NewportAuburn, Newquay, Newry, NGERULMUD, 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Dnipropetrovsk, Ulhasnagar, Ulyanovsk, Umm al-Qaiwain, Umm al-Quwain, Umm Bab, Umm Birka, Umm Ghuwailina, Umm Lekhba, Umm Qarn, Umm Salal Ali, Umm Salal Mohammed, United arab emirates, UNITED ARAB EMIRATES (UAE), united Kingdom, UNITED KINGDOM* (UK), United States, UNITED STATES OF AMERICA (USA), URUGUAY, UZBEKISTAN, Vadodara, VADUZ, Vale of Glamorgan, Valencia, VALLETTA MARSHALL ISLANDS, VANUATU, Varanasi, Varese, Vasai Virar, VATICAN CITY, VATICAN CITY (Holy See), VENEZUELA CARACAS, Venice, Verbano-Cusio-Ossola, Vercelli, Verona, Vibo Valentia, Vicenza, Victoria, Vienna, VIENTIANE, VIETNAM HANOI, Vijayawada, VILNIUS, Visakhapatnam, Viterbo, Vladimir, Volgograd, Vologda, Voronezh, Wadi Al Banat, Wadi Al Sail, Wadi Al Wasaah, Wadi Lusail, Wakefield, Wales, Warrington, Warsaw, Warwickshire, Washington, Wellington, Wells, West Berkshire, West Dunbartonshire, West Lothian, West Midlands, West Sussex, West Yorkshire, West Yorkshire (Bradford–Leeds), Western Australia, Western Isles, Westland, Whitehaven, Whitehorse, Wick, Wiltshire, Winchester, Windsor and Maidenhead, Winnipeg, Wisbech, Wokingham, Wolverhampton, Worcester, Worcestershire, Workington, Wrexham, Wrexham Qatar, Wycombe, YAMOUSSOUKRO, YAOUNDE, YAREN DISTRICT, Yaroslavl, Yellowknife, YEMEN SANA'A ZAMBIA, YEREVAN, York, Yorkshire and the Humber, Yukon, ZAGREB, ZIMBABWE, Zürich