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Alternative Health Experts LLC DBA Immunization Alternatives - 605884 - 04/06/2020
… … WARNING LETTER Date: April 6, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
NRP Organics Ltd - 606066 - 04/08/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/nrp-organics-ltd-606066-04082020 … WARNING LETTER Date: April 8, 2020 RE: …
Silfradent Srl - 592502 - 10/28/2019
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/silfradent-srl-592502-10282019 … WARNING LETTER October 28, 2019 Dear Mr. Batani: During an …
GPC Medical Ltd. - 536145 - 10/20/2017
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/gpc-medical-ltd-536145-10202017 … 10903 New Hampshire Avenue Silver Spring, MD 20993 WARNING LETTER VIA UNITED PARCEL SERVICE October 20, 2017 …
Lusys Laboratories, Inc. - 625807 - 02/17/2022
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/lusys-laboratories-inc-625807-02172022 … WARNING LETTER Date: February 17, 2022 TO: 7220 Trade St. …
Block Scientific - 609533 - 03/18/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/block-scientific-609533-03182021 … WARNING LETTER Date: March 18, 2021 RE: Adulterated and …
Lepu Medical Technology -Beijing- Co., Ltd. - 614908 - 07/29/2021
… … WARNING LETTER Date: July 29, 2021 RE: Adulterated and … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Vivera Pharmaceuticals, Inc. - 614412 - 07/26/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/vivera-pharmaceuticals-inc-614412-07262021 … WARNING LETTER Date: July 26, 2021 RE: Adulterated and …
Vivera Pharmaceuticals, Inc. - 614382 - 07/26/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/vivera-pharmaceuticals-inc-614382-07262021 … WARNING LETTER Date: July 26, 2021 RE: Adulterated and …
Pacific Center of Health/Pacific Center of Health & Acupuncture - 614526 - 06/22/2021
… … WARNING LETTER Date: June 22, 2021 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
EnMed MicroAnalytics, Inc. - 610131 - 01/25/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/enmed-microanalytics-inc-610131-01252021 … WARNING LETTER Date: January 25, 2021 RE: Adulterated and …
Ehy Holdings, LLC - 675591 - 02/02/2024
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/ehy-holdings-llc-675591-02022024 … WARNING LETTER February 2, 2024 RE: WL #2642 Dear Jabez Liu: …
Zen Enterprises LLC - 678407 - 04/18/2024
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/zen-enterprises-llc-678407-04182024 … WARNING LETTER April 18, 2024 RE: WL 2644 Dear Mr. Makima: …
TEI Biosciences, Inc. - 573474 - 03/06/2019
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/tei-biosciences-inc-573474-03062019 … Dear Mr. … reviewed your firm’s response to FDA 483 observations 1-3 (Warning Letter cite 1 and 2 above) and conclude they are not …
Lexion Medical LLC - 613588 - 07/26/2021
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/lexion-medical-llc-613588-07262021 … July 26, 2021 … on FDA's website of firms and websites that have received warning letters from FDA concerning the sale or distribution …
Oxford Performance Materials, Inc. - 523250 - 05/01/2017
… -compliance-enforcement-and-criminal-investigations/warning-letters/oxford-performance-materials-inc-523250-05012017 … … 4th floor Stoneham, MA 02180 Phone (781) 587-7500 WARNING LETTER CMS # 523250 … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
International Medsurg Connection, Inc. - 511426 - 05/08/2017
… -compliance-enforcement-and-criminal-investigations/warning-letters/international-medsurg-connection-inc-511426-05082017 … (312) 353-5863 Fax: (312) 596-4187 May 8, 2017 WARNING LETTER CHI-9-17 UPS NEXT DAY SIGNATURE REQUIRED … federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information …
Dynavision International LLC - 525321 - 09/05/2017
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/dynavision-international-llc-525321-09052017 … … Ave. Stoneham, MA 02180 September 5, 2017 WARNING LETTER CMS # 525321 VIA UNITED PARCEL SERVICE Mr. …
Centro Mas Salud Dr. Gualberto Rabell-Fernandez - 537596 - 12/21/2017
… # 200 Maitland, FL 32751 Telephone: (407) 475-4700 WARNING LETTER CMS#537596 … be provided to the referring physicians and lay summary letters to the patients within 30 days of the date of the … or for delivery to the referring physician. Lay summary letters may be directly given to a patient at the time of the …
CBD Gaze - 607299 - 05/26/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/cbd-gaze-607299-05262020 … WARNING LETTER Date: May 26, 2020 …
North Isle Wellness Center - 607947 - 06/19/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020 … WARNING LETTER Date: June 19, 2020 …
1 Party At A Time - 609781 - 09/01/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/1-party-time-609781-09012020 … WARNING LETTER Date: September 1, 2020 RE: …
H-Lab Life - 609528 - 08/07/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/h-lab-life-609528-08072020 … WARNING LETTER Date: August 7, 2020 TO: …
Pharmacy Plus, Inc. dba Vital Care Compounder - 610477 - 09/09/2020
… … WARNING LETTER Date: September 9, 2020 RE: … on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of …
Canadian Chaga - 609097 - 08/06/2020
… pections-compliance-enforcement-and-criminal-investigations/warning-letters/canadian-chaga-609097-08062020 … WARNING LETTER Date: August 6, 2020 …