US FDA Certification

US FDA labelling requirements for medical devices

US FDA labelling requirements for medical devices

If you need to sell your medical devices in the US, you need to comply with labelling requirements as set by the US FDA. Let’s understand the US FDA Labelling requirements for medical devices through this article. Name and Place of Business Labelling Requirement In the world of regulatory compliance, precision in labelling is important. … Read more

FDA Compliances for Exporting Food Products in USA

FDA Compliances for Exporting Food Products in USA

There is huge demand for food products and other items such as Drugs, Cosmetics, Colour Additives, Medical Devices, supplements, PPE Kits, etc. So, if you plan to export food products or any other such item to the USA, you must know about FDA compliance.  Mandatory FDA Compliances for Exporting Products to USA 1. US FDA … Read more

How to verify US FDA Certification?

How to verify US FDA Certification

The United States Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and efficacy of products available in the market. So, If you have received US FDA Certification or plan to get it, you must know about the process to verify US FDA Certification. Process to verify US FDA Certification The … Read more

Find out list of FDA “approved” & “not approved” products

Find out list of FDA approved & not approved products

In this article, you can find out the list of FDA “approved” and “not approved” products. What does FDA “Approved” mean? When the FDA grants approval to a drug, it signifies that CDER has thoroughly examined data regarding the drug’s effects. Furthermore, it concludes that the benefits it offers outweigh the known and potential risks … Read more

US FDA suspend eye product Indian Company

US FDA suspend eye product Indian Company

The manufacture of eye drops at the Chennai-based business has been halted by India’s Central Drugs Standard Control Organization (CDSCO) after the US FDA reportedly connected 55 adverse event instances to contaminated eye drops. Let’s read the latest updates for this news. US FDA suspends eye product production at Global Pharma site The Food and … Read more

US FDA Certification of Sun Pharma pulled up

US FDA Certification of Sun Pharma pulled up

Sun Pharma, a major pharmaceutical company, has been investigated by the health authority in the United States (US FDA Certification) for manufacturing rule violations that occurred at its plant in Gujarat. These transgressions include failing to follow appropriate written procedures designed to prevent the microbiological contamination of drug products. Sun Pharma gets Warning Letter from … Read more

US FDA Clearance vs US FDA Approval for Medical Devices

US FDA Clearance vs US FDA Approval for Medical Devices

It’s natural for us to think that everything FDA-cleared or authorised has undergone extensive testing, but that isn’t necessarily true. It is essential to be aware of the differences between US FDA Clearance vs US FDA Approval for Medical Devices. In this article, you will get to know about the US FDA Clearance vs US … Read more

Procedure to Import Cosmetic Products in India

Procedure to Import Cosmetic Products in India

India’s cosmetics market is nearly twice as large as those in the United States and Europe, and it is growing at an exponential rate. Because of the industry’s expansion, India’s Ministry of Health and Family Welfare has mandated that all items imported into the country must have a mandatory registration certificate. Consequently, whether you are … Read more

How to get US FDA Certificate in India?

How to get US FDA Certificate in India

If you want to export products in the USA, you need to comply with certain US Import and Export Formalities. One such mandatory requirement you need to fulfill is US FDA Certification. It is a basic requirement that you need to export products such as Food, Drugs, Cosmetics, Color Additives, Medical Devices, supplements, and even … Read more