What is a Warning Letter?

The FDA issues warning letters when a company breaks the FDA regulations. They usually send warning letters after FDA inspection and find big problems that can cause serious health issues to consumers. Warning letters contain information for the company like recall of products from the market or stop ...

What is an FDA 483?

The FDA 483 is a form that FDA issues to companies after inspection. It contains the list of violations of FDA regulations in the facility. This FDA 483 form gives the company a chance to fix the listed issues. An FDA 483 doesn’t always mean serious problems. Sometimes they are minor issues like improper ...

Tips for a Successful FDA Inspection

Preparation for FDA inspection in advance is key to having a successful FDA inspection. Here are some useful tips to prepare for FDA inspection. 1. Completely understand your products and processes to make the required changes. FDA looks for the documentation and also asks questions related to manufacturing ...

The US-FDA has approved Tirzepatide for chronic weight management in adults with Obesity

Today, the U.S. Food and Drug Administration approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kilograms per square meter (kg/m2) or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition ...

FDA Form 483

“Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections. Q: What is FDA’s ORA? A: Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. During an inspection, ...

FDA Drug Recall Process

On average, 4500 drugs and medical devices are pulled from shelves across the United States each year, because of product recalls. Drugs can be recalled, because of a variety of reasons, including issues involving drug contamination, safety, changes in potency, or mislabeling. Although recalls aim to ...

FDA Warning Letters for Cleaning Validation

Cleaning of equipment was first published in the Code of Feral Regulations (CFR) as 21CFR211.67 Equipment Cleaning and Maintenance in 1978. After that a lot of document guidelines are published on cleaning validation and nowadays cleaning validation is the main focus area of FDA GMP inspections. In ...

FDA 21 CFR Part 11

21 CFR Part 11 is a regulatory framework designed by the FDA to guide drugmakers on how to create, manage, and maintain electronic records and electronic signatures. It also says under what conditions drug makers become eligible for compliance with this regulation. The term comes from Title 21 of the ...

FDA Guidance for industry states Airlocks

“Air change rate is another important clean room design parameter. For Class 100,000 ( ISO 8 ) supporting rooms, airflow sufficient to achieve at least 20 air changes per hour is typically acceptable.” Design requires hard numbers, so there is temptation for the design team to use this statement ...

FDA facility inspection

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