The US FDA has issued guidance to the pharma industry on circumstances that constitute delaying, denying, limiting, or refusing a drug inspection. The regulatory major is seeking industry comments to this effect by September 30, 2013.
In the wake of the new regulations and the possibilities for the production of spurious and not of standard quality drugs, the US FDA is now keen to address four issues through its draft guidelines. First is on the delay of inspections where companies postpone scheduling pre-announced inspections, put off an inspection and postpone producing records. The second is on the denial of inspection. Third is limiting of inspection which includes the access to facilities, photography, copying of records and preventing collection of samples. The fourth is on the refusal to permit entry or inspection.
The Indian pharma companies Biocon, Strides Arcolab, Micro Labs and Bal Pharma have stated that the guidance is in sync with the current developments where transparency is the need of the hour for a successful inspection of a facility.
On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. Section 707 of FDASIA adds 501(j) to the FD&C Act to deem an adulterated drug manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner or operator, delays, denies, or limits an inspection and refuses to permit entry or inspection.
Section 707(b) of FDASIA mandated that the FDA, not later than one year after the date of enactment of FDASIA, to issue a guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection.
According to the regulatory authority, this draft guidance defines the types of actions and circumstances that the FDA considers in the delay and denying inspection.
Section 704(a) of the FD&C Act calls for inspections by duly appointed FDA employees to enter, at reasonable time, and inspect, within reasonable limits.
“An FDA inspection is a careful, critical, official examination of a facility to determine its compliance with certain regulations,” said the regulatory authority.
Now under the draft guidance clause related to inspections delay, it may occur for many reasons, some of which are beyond the control of the facility. However, where an owner, operator or agent causes the delay of an inspection may cause the drug to be adulterated under section 501(j) of the FD&C Act.
The regulatory authority stated that the pre-announcement of an inspection is intended to facilitate the process and ensure that appropriate records and personnel will be made available. Generally, for drug products, pre-approval and pre-license inspections, most assessment of foreign facilities are scheduled before an investigator arrives at the inspection site.
When actions by a facility’s owner impedes an FDA investigator from checking the premises in a reasonable manner may be considered delaying the inspection. FDA is aware that its appearance on-site may initially cause some minor confusion and inconveniences to the facility’s employees. Minor delays generally would not be considered unreasonable.
Further, if a facility rejects FDA’s attempt to schedule an inspection and withdraws the same without a reasonable explanation it is a violation of the guidance.
Photographs are an integral part of an FDA inspection because they present an accurate picture of facility conditions. Not allowing photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigators to be necessary to effectively conduct that particular inspection, said the regulatory authority.