Norms on conditions to delay and deny drug inspection issued by USFDA

As stated by the pharmaceutical industries the guidance is important from the perspective of stringent regulatory norms and frequent inspections by the international regulatory bodies. Violations in quality standards were observed in the manufacturing plants between 2011 and 2013 and distraction of inspection teams during audits and sharing false information was also observed.

Delays may occur for many reasons but if an owner, operator causes the delay of an inspection, it could be suspected that the drugs are adulterated under section 501(j) of the FD&C Act. Efforts to schedule pre-announced inspections include communicating to the facility’s point of contact including the unit’s US representative if the production plant is a foreign facility. It will make adjustments to inspection based on local conditions like weather or security situations, holidays and other non-working days.

In the guidance examples have been cited illustrating situations faced in preparing and conducting inspections. Section 704 of the FD & C Act states what is necessary to achieve the objective of the inspection. The regulator intends to work with facilities to conduct inspections and procure the information necessary to achieve the objective of the inspection. Therefore facilities required to register under section 510 of the FD&C Act and voluntarily register as outsourcing facilities under section 503B of the FD&C Act have to submit certain information to the regulator.

The guidance defines the circumstances under which inspection can be refused or delayed. This guidance clearly clarifies the expectations of the FDA. It will ensure that the companies will be prepared accordingly and it will also avoid misunderstandings.

Once a company agrees voluntarily in writing to allow FDA to inspect the premises, it is well within the rights of the regulator to prescribe guidelines to achieve the objectives of inspection. IGMPI