FDA 483 | What Is FDA Form 483

What is commonly known as FDA 483 is actually FDA Form 483, the way in which Food and Drug Administration inspection inspectors list out the unsatisfactory results and detail of manufacturing facilities for compliance with good practice and current manufacturing (cGMP). The FDA inspects plants, which make human medications (both prescription and over-the-counter), animal and veterinary drugs, health products, food, radiation-emitting products, vaccines, blood, and biological and cosmetic products for cGMP compliance.

 

FD&C Law

The FDA's authority to inspect factories is detailed in Section 704 of the Federal Food, Drug and Cosmetic Act. The law authorizes officials or other FDA employees to enter any establishment where "food, drugs, [medical] devices, or cosmetics are manufactured, manufactured, packaged, or performed" for the purpose of inspection the establishment and materials in it. Section 704 requires the inspector to provide the owner or operator with a report detailing the deficiencies before leaving the establishment.

 

CGMP

FDA regulations expect companies that manufacture either the ingredients of the drugs (both pharmaceutical active ingredients and inactive ingredients such as excipients) or finished drugs (in their final dosage forms) to be called cGMP. The cGMP for finished drugs is outlined in 21 CFR Chapter 1 of Article 211, which covers 58 topics, including responsibilities for quality control, lighting, ventilation, and design and maintenance equipment.

 

inspections

The FDA is authorized to inspect plants in which Active Pharmaceutical Ingredients (APIs) are manufactured in connection with the approval of final drugs in which API is used, and these plants are required to submit what they are called " Drug Master Files "with the FDA. Because a number of manufacturers of both APIs and finished drugs are located outside of the United States, the FDA is authorized to inspect plants and plants located outside of the domestic United States.

 

form 483

Section 704 requires the inspector to provide the owner or operator with a report detailing the deficiencies before leaving the facility - namely, a Form 483. A Form 483 will list the categories in which deficiencies have been found and offer observations that detail each one of said deficiency. For example, Form 483 filed after inspection of a McNeil Consumer Products plant provides comments on the quality system, the labelling and packaging system, laboratory operations, the materials system, and facilities and equipment.

 

Conflict resolution

If a drug manufacturer has pending FDA approval for drugs manufactured in a facility for which a Form 483 letter has been issued, the FDA may withhold approval of the drugs pending satisfactory resolution of your concerns. The FDA has produced a document, or "Industry Guide," detailing its formal conflict resolution system for scientific and technical issues related to the cGMP, although the guidance suggests that manufacturers seek to agree with the FDA inspector informally, if possible.