USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma

April 5, 2016September 11, 2024 Pharmaceutical Guidanace

USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma

Noven Pharmaceuticals, Inc. 8/5/16

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Frontida BioPharm Inc 8/15/16

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Mappel Industria de Embalagens S.A. 9/12/16

Cheng Fong Chemical Co., Ltd. 9/15/16

Yangzhou Hengyuan Daily Chemical Plastic Co Ltd 9/26/16

Laboratoire Sintyl S.A. 9/29/16

Delarange Cosmetics BV 9/29/16

Austin Biotechnology Inc. 6/2/16

S.R. Burzynski Manufacturing Facility 6/13/16

Sri Krishna Pharmaceuticals Ltd. – Unit II 4/1/16

Emcure Pharmaceuticals Limited 3/3/16

Ipca Laboratories Limited 1/29/16

Millers of Wyckoff, Inc. 6/7/16

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Audit and Guideline 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, 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Derbyshire, Derbyshire Dales, Derry, Derry and Strabane, Devon, DHAKA, Djelfa, DJIBOUTI, DJIBOUTI (CITY), DODOMA, Doha, Dombivali, DOMINICA, DOMINICAN REPUBLIC, Donetsk, Dorset, Dover, dubai, Dublin, Duhail, Dukhan, Dumfries and Galloway, Dunbar, Dundee, Dunkeld, Duns, Dunstable, Durgapur Asansol, Durham, DUSHANBE, East Ayrshire, East Devon, East Dunbartonshire, EAST JERUSALEM, East Lothian, East Midlands, East of England, East Renfrewshire, East Riding of Yorkshire, East Sussex, ECUADOR, Eden, Edinburgh, Edmonton, Egypt, El Eulma, El Oued, EL SALVADOR, Elgin, Ely, England, Enna, EQUATORIAL GUINEA, Erewash, ERITREA, Espirito Santo, Essex, estado, estados, ESTONIA, ESWATINI (formerly Swaziland), ETHIOPIA, Exeter, Fairview, Falkirk, Falmouth, Faridabad, Fenland, Fereej Abdel Aziz, Fereej Al Amir, Fereej Al Asiri, Fereej Al Asmakh, Fereej Al Manaseer, Fereej Al Murra, Fereej Al Nasr, Fereej Al Soudan, Fereej Al Zaeem, Fereej Bin Durham, Fereej Bin Mahmoud, Fereej Bin Omran, Fereej Kulaib, 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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, 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Kinross, peru, Perugia, Pesaro and Urbino, Pescara, Peterborough, Philippines, PHNOM PENH, Piacenza, Piaui, Pimpri, Pisa, Pistoia, Plymouth, Poland, Poole, Pordenone, PORT LOUIS, PORT MORESBY, PORT OF SPAIN, PORT VILA, PORT-AU-PRINCE, Porto Portugal, PORTO-NOVO, Portsmouth, portugal, Potenza, Powys, Prague, PRAIA, Prato, Preston, PRETORIA, Prince Edward Island, PRISTINA, Pskov, Pune, PYONGYANG, Qatar, Quebec City, Queensland, QUITO, Ragusa, Raipur, Rajkot, Ramsey, Ranchi, Ras Abu Aboud, Ras Al Khaimah, Ras Lafan, Ravenna, Rawdat Al Hamama, Rawdat Al Khail, Rawdat Egdaim, Rawdat Rashed, Reading, Redcar and Cleveland, Reggio Calabria, Reggio Emilia, Regina, Relizane, Renfrew, Renfrewshire, Repton, REYKJAVIK, Rhondda Cynon Taf, Rieti, RIGA, Rimini, Rio de Janeiro, Rio Grande, Ripon, Riverside, RIYADH, Romania, Rome, ROSEAU, Rostov, Rotterdam, Rovigo, Rumeilah, Russia, Rutland, RWANDA, Ryazan, Saharanpur, Saïda, SAINT GEORGE'S, SAINT JOHN'S, SAINT KITTS & NEVIS, SAINT LUCIA, Saint 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Lanka, Srinagar, St Albans, St Asaph, St Davids, St. Austell, St. Ives, St. John's, Staffordshire, Stirling, STOCKHOLM, Stockton-on-Tees, Stoke Poges, Stoke-on-Trent, Stuttgart, SUCRE, sudan, Suffolk, Sunderland, Surat, SURINAME, Surrey, SUVA, Sverdlovsk, Swansea, Sweden, Swindon, switzerland, Sydney, Syracuse, SYRIA, TAJIKISTAN, TALLINN, Tambov, TANZANIA, Taranto, TASHKENT, Tasmania, TBILISI, Tébessa, TEGUCIGALPA, TEHRAN, Telford, Telford and Wrekin, Teramo, Terni, Thailand, Thane, The Hague, The Pearl, THIMPHU, Thiruvananthapuram, Thuringia, Thurrock, Thurso, Tiaret, TIMOR-LESTE DILI, Tintagel, TIRANA, Tiruchirappalli, Tizi Ouzou, Tlemcen, TOGO, TOKYO, Tomsk, TONGA NUKUʻALOFA, Torbay, Trapani, Trento, Treviso, Trieste, TRINIDAD & TOBAGO, TRIPOLI, Truro, Tula, TUNIS, TUNISIA, Turin, turkey, TURKMENISTAN, TUVALU, Tver, Tyne and Wear, Tyumen, Udine, UGANDA, Ujjain, Ukraine, Ukraine. 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

USFDA WARNING LETTER 2016 (Finished Pharmaceuticals) in Pharma

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