Refusal to Permit Inspection - What are the Consequences?

Inspections are a regulatory requirement in the GMP environment. This also applies to the USA. But what happens if a manufacturer simply refuses to permit a GMP inspection?

A Mexican glycerin manufacturer refused a pre-announced inspection by the FDA. How did the FDA react? It pointed out in its Warning Letter to the glycerin manufacturer that the firm is known to be a supplier of starting materials for the manufacture of drug products in the USA. Furthermore, the FDA stressed that the use of glycerin contaminated with diethylene glycol had resulted in various lethal poisoning incidents in the past. 

Referring to the "Federal Food, Drug, and Cosmetic Act" the FDA indicated that the refusal to permit inspection leads to the products of the relevant manufacturer to be regarded as adulterated. The firm was then placed on import alert.

The FDA threatened to withhold approval of any new applications for marketing authorisations in which the manufacturer is listed as supplier of starting materials until the FDA is permitted to inspect the facility. In this case not only the manufacturer itself is affected by the import alert but also customers who use the manufacturer's glycerin and apply for a new marketing authorization. The FDA continues in its Warning Letter that other products of the manufacturer which could be adulterated will also be detained accordingly.  

Conclusion: Refusing an inspection does not help.

For more detailed information please see the complete FDA Warning Letter to Glicerinas Industriales.