Inspection of Cosmetics

What manufacturers need to know about FDA inspections

The U.S. Food & Drug Administration (FDA) has the legal authority to inspect cosmetic establishments as well as cosmetics offered for import. As a manufacturer you should understand how FDA is conducting inspections and what you should consider to be well prepared.

Duration and extent of the inspection depends on the reason for the inspection

Before the inspection can be officially carried out, the FDA investigator must present credentials and a written notice of inspection. There are several factors that can cause an inspection within an establishment. A significant increase of consumer or trade complaints is a likely reason for an investigator to show up. In such cases the company's compliance history becomes subject of inspection as well. Other factors that justify an inspection are the type of products the establishment is manufacturing or FDA surveillance and compliance initiatives. The length of an inspection varies as it is dependent from the reasons for the inspection and the size of the establishments. In the event that the investor finds anything untoward, the inspection may be extended.

Anything can become a subject of investigation

The way in which the investigator proceeds and what he investigates can influence the duration of the visit. An investigator can look into everything without exception. They may look for prohibited ingredients or improper use of restricted ingredients, noncompliance with requirements or any kind of contamination. They may also look for deficiencies in packaging and labeling and failure to adhere to requirements for tamper-resistant packaging where needed. The buildings and facilities of the establishment as well as the suitability of equipment and its maintenance may also become a subject for inspection.
The investigator not only checks processes in the establishment, they also takes samples to analyze them afterwards. Such samples may be cosmetic ingredients or finished products, in-process products, swabs of equipment, product contact surfaces, or any other materials that serves to document product adulteration or misbranding.
After the inspection the FDA determines from the information gathered whether or not a product is adulterated or misbranded. The FDA include in its decision both the information gathered by the inspector during the visit and the samples obtained. In contrast to pharmaceutical products, there are no good manufacturing practice (GMP) regulations for cosmetics. Instead, there are Good Manufacturing Practice Guidelines and manufacturers are encouraged to comply with the inspection checklist to prevent adulterated or misbranded products.

Same requirements for imported products

Cosmetic products that are imported to the USA must comply with all the regulatory requirements that apply to domestic products. U.S. Customs and Border Protection examines products at the time of entry. All shipments that don't comply with the regulations must be brought into compliance, destroyed or re-exported.

Further reading:
FDA Cosmetics