AHPAs plea to FDA to include regulations on Form 483
The American Herbal Products Association’s petition aims at making a connection between the regulatory agency, FDA and the industry. According to this plea, the agency can cite specific regulations related to the inspection of food and drug facilities and the observations of which are noted in the Form 483 issued to the concerned manufacturing company. While there is a mention of specific regulations if a Form 483 advances to warning letters, the same can be done for Form 483.After the FDA inspectors have inspected a dietary supplement unit, the inspectors, cite their observations related to cGMP violations in the Form 483. According to AHPA, presently, the inspectors are not permitted to quote regulations when mentioning the observations. This can cause confusion and leave the industry players to keep guessing about the exact regulatory requirements. The manufacturers may not be able to understand the precise regulation that the agency is referring to when citing about any cGMP violation. This not only slows down the GMP compliance issues resolution process but also affects the whole working process.
Instead, if the regulatory requirements are clearly cited, it can make the process simpler and help the industry. Once the manufacturers know the regulation, they can meet the requirements.