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July 12, 2022

DDI Multinacional S.A. de C.V. – 608864 – 06/27/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Angelica Flores Recipient Title Chief Executive Officer DDI Multinacional S.A. de C.V. Javier Espinoza No. Mz. […]
July 12, 2022

1am USA Incorporated dba Pleasure Products USA – 627006 – 07/01/2022

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER July 1, 2022 […]
July 12, 2022

Thirsty Run LLC / US Royal Honey LLC – 623359 – 07/01/2022

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER July 1, 2022 […]
July 12, 2022

MKS Enterprise, LLC – 624478 – 07/01/2022

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER July 1, 2022 […]
July 12, 2022

Shopaax.com – 626291 – 07/01/2022

Delivery Method: Via Overnight Delivery Product: DrugsFood & Beverages Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States WARNING LETTER July 1, 2022 […]
July 11, 2022

Notify FDA of Illegitimate Products

The Drug Supply Chain Security Act (DSCSA) requires certain trading partners – manufacturers, repackagers, wholesale distributors, and dispensers to notify FDA and all appropriate immediate trading […]
July 11, 2022

FDA Compounding Quality Center of Excellence Cross-Sector Stakeholder Group

The FDA established a cross-sector stakeholder group to engage on issues that affect outsourcing facilities, health care providers that purchase and use their products, and other […]
July 11, 2022

Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines – 08/16/2022

On This Page Date: August 16 – 18, 2022 Day1: Tue, Aug 16 8:30 AM – 12:30 PM ET Day2: Wed, Aug 17 8:30 AM – […]
July 8, 2022

January – March 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Accidental exposure to product by child FDA is evaluating the need for regulatory action. Betadine (povidone-iodine) E-Z Prep (povidone-iodine) E-Z Prep 220 (povidone-iodine)   […]
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