Tag Archives: Aberdeenshire

FDA Pharma Warning Letter -September 2023 During an inspection of your firm located at 22 Cherry Hill Drive, Danvers, MA on March 1, 2023 through April 13, 2023, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a Medical Device Manufacturer of class III …

FDA Pharma FDA Warning Letter September 14, 2023 The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Fenwal International, Inc. (a Fresenius Kabi company), located at Road 357, Km 0.8, Maricao, PR 00606, between September 12, 2022 and September 24, 2022. During the inspection, the …

FDA Warning Letter September 1, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, PureChemPros LLC, FEI 3019411371, at 2141 E. Cedar Street, Suite 6, Tempe, from November 17 to November 22, 2022. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations …

Pharma FDA Warning Letter 9/11/2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility Kor-Chem, Inc., FEI 3000204701, at 5800 Bucknell Drive SW, Atlanta from April 26 to May 5, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. …

Pharma FDA Warning Letter  September 5, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Safecor Health LLC, FEI # 1218914 at 317 New Boston St., Woburn, Massachusetts, from March 7 to 16, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) …

Pharma FDA Warning Letter September 5, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Safecor Health LLC, FEI # 1218914 at 317 New Boston St., Woburn, Massachusetts, from March 7 to 16, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) …

Pharma FDA Warning Letter September 11 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Similasan AG, FEI 1000110034, at Chriesiweg 6, Jonen, from March 27 to April 4, 2023. This letter is to advise you that FDA reviewed the information related to the inspection, including Similasan’s …

                  Pharma FDA Warning Letter 17 August 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Lex Inc., FEI 1031041, at 7155 NW 77th Terrace, Medley, Florida, from February 13 to February 28, 2023. This warning letter summarizes …

Pharma FDA Warning Letter 23 August 2023 Your facility was registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 3, 2023 request for records and other information pursuant to …

Tismor Health and Wellness Pty Limited MARCS-CMS 588104 — December 05, 2019 For Warning Letter Click Here –   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. For …

Sunstar Guangzhou Ltd. MARCS-CMS 592906 — January 22, 2020 For Warning Letter Click Here –   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. For more USFDA warning …

Dental-Kosmetik GmbH & Co. KG MARCS-CMS 591351 — January 16, 2020 For Warning Letter Click Here –   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. For more …

Baja Fur S.A. de C.V. MARCS-CMS 590791 — December 13, 2019 For Warning Letter Click Here –   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. For more …

Essnd Global MARCS-CMS 595850 — February 14, 2020 For Warning Letter Click Here –   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. For more USFDA warning Letter …

JHS Svendgaard Hygiene Products Ltd MARCS-CMS 593473 — February 13, 2020 For Warning Letter Click Here –   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. For more …

KVK-Tech, Inc MARCS-CMS 592387 — February 11, 2020 For Warning Letter Click Here –   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. For more USFDA warning Letter …

Chemland Co., Ltd. MARCS-CMS 593158 — February 11, 2020 For Warning Letter Click Here –   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. For more USFDA warning …

Acino Products, LLC MARCS-CMS 589471 — February 10, 2020 For Warning Letter Click Here –   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. For more USFDA warning …

Guangzhou Tinci Materials Technology Co., Ltd. MARCS-CMS 592199 — January 23, 2020 For Warning Letter Click Here –   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. For …

Windlas Healthcare Private Limited MARCS-CMS 595494 — March 10, 2020   For Warning Letter Click Here –   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. For more …