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 ...
How to Prepare for a GMP Audit in Pharmaceuticals Industry?
GMP audit is a process by which an external or internal individual or team verifies that a manufacturer is following its documented Good Manufacturing Practices.
GMP audit of any pharmaceutical industry is very critical and important in the terms of its business. Therefore, the preparations for the audit ...
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 ...
Self Inspection
1. Introduction:
Self-inspection is essentially a method of objective overall review of one’s operation on aspects that may have a quality impact on quality assurance. In general, self-inspection aims to identify defects that are critical, major or minor in nature. Self-inspection should be carried ...
