A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would be considered to obstruct an FDA inspection and potentially lead to a supposition of adulteration. Last month, the final guidance was issued. The document attempts to define what behaviors are considered to mean an intentional delay or refusal. The FDA has the authority to enter any facility under the jurisdiction of the FD&C Act at reasonable times and conduct inspections.
Delays of an Inspection
Some inspections are pre-scheduled. The investigator will contact the facility and negotiate an acceptable date. Reasonable considerations can include holidays, weather or other local issues beyond the company’s control. An example might be if the local utility company is digging up the road outside the facility or working on power lines, it may not be the best time for an inspection.
Adulteration may be indicated if the facility:
- fails to agree to a date and can’t provide a reasonable explanation
- changes the agreed upon date without providing a reasonable explanation
- is unresponsive to communications
Delays During an Inspection
This is probably the more common behavior. Any activity that impedes the investigator while at the site from conducting the investigation can be categorized as a delay. Minor delays are expected and will probably be accepted with a reasonable explanation. An example might be that an SME is out of town but you are trying to reach them by phone. A particular service may be outsourced and you are arranging a conference with the appropriate individuals may be another acceptable consideration.
A citation may result if:
- A facility does not allow access to a particular area and cannot agree on a time when that can occur.
- A facility leaves an investigator in a room without anything to review beyond a reasonable period of time.
In the previous example, there is really nothing stopping the investigator from leaving the room and wandering around the facility unescorted.
Delay of Providing Records
The records are the holy grail of your processes. The FDA recognizes reasonable explanations such as record storage is off site or a particular request is large and will need additional time to compile. There are off site record vendors that provide 24 hour delivery. Reviewing records electronically is another option to fulfill the request. An unacceptable delay is determined when a facility fails to provide the records in a reasonable timeframe.
Limiting Inspections
This is a broad category of behaviors that may include
- Limiting access to a particular building or area
- Limiting photography
- Limiting access to an employee to conduct an interview
- Limiting access to specific records
- Preventing copies of records or taking samples
Refusal of Entry or Denial of Inspection
This can include hindering the FDA from conducting or completing an investigation. This may be through direct actions or passive behavior with the intent to avoid, mislead, deceive or impede the investigation.
This may include:
- Refusing entry without a reasonable explanation
- Repeated rejections of attempts to schedule the investigation
- Unresponsive to communications
- Falsely reporting the facilities use
Answer the Door
The FDA expects cooperation from each facility to attain the objectives of the inspection. Every company should be inspection ready at all times. Understand what is required during an inspection. Maintain inspection procedures and train staff on how to handle an inspection. When the facility is in tip top shape and the documents are in order, you’ll be primed for when the doorbell rings.