What does FDA compliance mean in detail?
Products are considered FDA-compliant when their manufacturing, materials, and processes meet the requirements of the relevant FDA regulations (e.g., 21 CFR). Abbreviated as FDA, it is the authority responsible for overseeing the safety of food and drugs in the United States. It is also responsible for medical devices, vaccines, and cosmetics.
A blanket FDA audit is not a prerequisite for U.S. sales. Market entry depends on the product category: drugs require FDA approval (NDA/ANDA; pre-approval inspections may occur), most medical devices are marketed via 510(k) clearance or De Novo classification (PMA devices undergo preapproval inspection), while foods and cosmetics do not undergo premarket approval (with exceptions such as additives/color additives). Mere “GMP recognition” is not sufficient.
Why is US FDA compliance important?
Pharmaceutical companies that are not FDA-compliant are prohibited from marketing their products in the USA.
US FDA compliance ensures that products are manufactured according to high safety standards – especially for drugs and medical devices.
Companies that have been audited by the FDA enjoy a high reputation – the FDA is considered one of the strictest regulatory authorities. Therefore, FDA compliance is a mark of quality.
What are the FDA’s requirements for the pharmaceutical industry?
Personnel
Medicines must be manufactured in compliance with GMP guidelines. Training, documentation, and the four-eyes principle are mandatory.
Raw and auxiliary materials
Under 21 CFR 211.84, each lot of raw and auxiliary materials must be tested against written specifications with at least one specific identity test. USP–NF standards apply when the material or drug is recognized in USP–NF or labeled as USP.
Analytical instruments
Must be regularly maintained and calibrated to ensure valid results.
Machines
For pharmaceutical equipment, product-contact surfaces must be non-reactive, non-additive, and non-absorptive (21 CFR 211.65); containers/closures must be suitable and controlled (21 CFR 211.94).
Chemicals and standards
Only pure and suitable chemicals, as well as qualified reference standards, may be used.
Semi-finished and finished products
They are checked by quality control. Only products within FDA standards may be packaged and sold.
Stability samples
Stability programs are required by 21 CFR 211.166. If a deviation in distributed batches presents a significant quality issue, the NDA/ANDA holder must submit a Field Alert Report within three working days per 21 CFR 314.81(b)(1); any recall is risk-based, not automatic.
How can FDA-compliant products be identified?
For medical devices, the label must bear a Unique Device Identifier (UDI); 510(k) numbers or establishment registration numbers are not required on the package. For drugs, the NDC often appears on labeling but is not mandatory.