FDA Regional Field Office 4B

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Pursuant to Memorandum Circular No. 116, RFO 4B (MIMAROPA) will implement a work-from-home arrangement tomorrow, April 1, 2026, from 8:00 AM to 12:00 PM. Work is suspended in the afternoon.

To all clients of RFO 4B, we encourage you to send your concerns and inquiries via email at [email protected].

You may also visit the FDA website at www.fda.gov.ph for more information, portals, and other contact details.

Face-to-face office operations will resume on April 6, 2026.

Thank you, and stay safe everyone.

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Half-day WFH for government employees tomorrow, April 1, 2026, Holy Wednesday. | via Ivan Mayrina/GMA News

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***FDA Advisory No.2026-0405 || PUBLIC HEALTH ADVISORY ON US-FDA ANNOUNCEMENT ON EXTENSIVELY DRUG-RESISTANT SALMONELLA IN MORINGA POWDER***

The Food and Drug Administration (FDA) hereby informs the public that the United States Food and Drug Administration (US‑FDA), in coordination with their Centers for Disease Control and Prevention (CDC) and local authorities, is investigating an outbreak of Salmonella Newport Infections linked to ROSABELLA Moringa Dietary Supplement distributed by Ambrosia Brands LLC.

The US‑FDA advises that certain lots of this dietary supplement, sold in white plastic bottles with a green label and expiration dates in 2027 has ongoing recall due to possible contamination with Salmonella1.

Read more:-> https://tinyurl.com/y3b82swp

Licensing Seminar for Drug Establishments (LS-D)

A licensing seminar for FDA Center for Drug Regulation and Research (CDRR) stakeholders which aims to provide information on the rules and regulations prescribing the requirements and procedures in the application for License to Operate (LTO) for drug establishments. The discussion also include current schedule of fees and charges and processing time.

Join our webinar on 21 May 2026 from 8:00 am to 12:00 nn via Google Meet
Registration fee: Php 500.00
Register through this link: bit.ly/4bOPPIK

Maximum of 800 participants
First-come-first-served basis

All successful registrants/applicants shall wait for the confirmation email from the FDA Academy for the issuance of Course Assessment Slip (CAS) and payment instruction pursuant to FDA Circular 2023-010.

Payments made without the corresponding CAS from the FDA Academy shall be forfeited.

***FDA Advisory No.2025-0856-A || Lifting the Advisory of the Registered Food Product under FDA Advisory No. 2025 – 0856 with Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product ‘JUNGLE JUICE Refreshing Orange Flavored Drink”***

The Food and Drug Administration (FDA) informs the public that the food product JUNGLE JUICE Refreshing Orange Flavored Drink has been registered by the Market Authorization Holder (MAH) Traditional Food Corporation in accordance to existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2025 – 0856 is hereby updated to remove the aforementioned food product.

Read more:-> https://tinyurl.com/3dh7kftb

Eid Mubarak!

Nakikiisa kami sa ating mga kapatid na Muslim sa pagdiriwang ng Eid al-Fitr bukas, Biyernes, March 20, 2026.

Alinsunod sa Proclamation No. 1189, sarado ang aming tanggapan sa nasabing araw bilang paggalang sa selebrasyon. Magpapatuloy ang operasyon sa Lunes, March 23, 2026, mula 8:00 AM hanggang 5:00 PM.

Maraming salamat at mapayapang pagdiriwang sa lahat!
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***FDA Advisory No.2021-3198-A || Lifting of the FDA Advisory No. 2021-3198 entitled Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Product “OREX DIGITAL THERMOMETER”***

The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product Orex Digital Thermometer, has been issued an FDA Certificate of Medical Device Registration (CMDR) to the Market Authorization Holder (MAH), Orex Health Solutions Inc. in accordance with the existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the products as mentioned in FDA Advisory No.2021-3198 dated 26 November 2021 is hereby lifted.

Read more:-> https://tinyurl.com/38pkb4ze

***FDA Advisory No.2023-0754-A|| Lifting of the FDA Advisory No. 2023-0754 entitled Public Health Warning Against the Purchase and Use of the Unnotified Medical Device Product “OREX GAUZE BANDAGE” ***

The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product Orex Gauze Bandage, has been issued an FDA Certificate of Medical Device Notification (CMDN) to the Market Authorization Holder (MAH), Orex Health Solutions Inc. in accordance with the existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the products as mentioned in FDA Advisory No. 2023-0754 dated 20 April 2023 is hereby lifted.

Read more:-> https://tinyurl.com/mucjar9w

All comments can be sent at [email protected]. Deadline of submission of comments shall be by 24 April 2026.

I. RATIONALE
Pursuant to Administrative Order (A.O.) No. 2024-0015, “Prescribing the Rules, Requirements, and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration, Repealing A.O. No. 2020-0017,” and as part of its commitment to continuous quality improvement, the Food and Drug Administration (FDA) continues to strengthen institutional efficiency through the implementation of a robust Quality Management System (QMS). This initiative supports the FDA’s ongoing efforts to accede to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and be a World Health Organization (WHO) Listed Authority (WLA).
These international standards strongly recommend having a standardized format and content for authorizations on pharmaceutical manufacturing. By aligning as well the authorization issued for other regulated pharmaceutical establishments, the FDA ensures consistency, transparency, and proper monitoring across all issued licenses. This also facilitates compliance with internationally accepted practices and promotes ease of verification by both local and foreign regulatory bodies.
In line with these initiatives, the FDA issues this Circular to establish the contents of License to Operate (LTO) issued by the FDA for pharmaceutical establishments.

See more:-> https://tinyurl.com/yznu4d9a