Laboratory Manual

Due to the 2024 FDA reorganization, ORA Lab Manual has been updated to reflect the organizational changes. The copy below is archived and is not being updated but will continue to be available at this location. For the new FDA Regulatory Testing Laboratory Manual of...

Kabana Skin Care LLC – 710232

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-94 Product: Drugs Recipient: Recipient Name Mr. Erik L. Kreider Kabana Skin Care LLC 685 S Arthur Ave Unit 9bLouisville, CO 80027-3141United States Issuing Office: Center for Drug Evaluation and Research...

Macsen Drugs – 698202 – 03/05/2025

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-51 Product: Drugs Recipient: Recipient Name Mr. Achal Agrawal Macsen Drugs F-261, 262, 263 Riico Industrial Area, GudliTehsil Mavli, Udaipur 313024RajasthanIndia Issuing Office: Center for Drug...

www.portmeds.com – 711585 – 07/16/2025

Recipient: www.portmeds.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug AdministrationRE: Notice of Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over...