For businesses that experienced a lull in Food and Drug Administration inspections during the pandemic, or have never faced one at all, the prospect of a visit from the FDA might be cause for alarm.
That trepidation might be greater in some industries, such as pharmaceutical manufacturing, that experienced up to triple the number of site visits year over year in 2022, bringing the frequency back up to pre-pandemic norms.
Whether a manufacturer of medical parts or a packaged food maker, the reality is that in-person surveillance inspections are a part of normal operating procedure, and year-round readiness is important to not just remain FDA-compliant, but to guarantee a safe product that meets high quality standards.
Read on for a refresher on how FDA inspections work and how to be prepared.
When to expect an inspection
There are three main types of inspections a manufacturer may undergo:
- Surveillance inspections: Used to monitor the manufacturing process and the quality of distributed drugs, the FDA uses the findings to evaluate whether a manufacturer is complying with the agency’s Current Good Manufacturing Practice requirements.
- Pre-approval inspections: Conducted as part of the review of an application to market a new drug, device or biologic, these inspections are used for approximately 20% of application reviews by the agency.
- For-cause inspections: Inspections that are triggered when the FDA has reason to believe that a facility has manufacturing quality issues or when the agency wants to evaluate corrections that have been made to address previous violations.
While the latter three three types of inspections are triggered by approval processes, violations or other irregularities, all manufacturers must be ready for a surveillance inspection, which don’t follow a prescribed frequency, FDA spokesperson Charles Kohler said.
Surveillance inspections are based on risk factors outlined in the FDA’s “risk-based site selection model,” which it uses to guide how to prioritize different sites for review. Factors include the company’s compliance history, as well as any “inherent risks” of the product manufactured.
High-risk food facilities in the U.S. are to be inspected at least once every three years, while lower-risk food facilities are to be inspected at least once every five years, according to the FDA.
Rob Dongoski, global lead for food and agribusiness at Kearney, said that industries with higher risks might, for instance, include poultry and pork, given salmonella and listeria outbreaks the sectors have respectively experienced in recent years.
How to prepare for an FDA surveillance inspection
Documentation is key to passing an inspection.
One of the best starting places for a small- to medium-sized manufacturer is to have a solid quality management system in place, said Kearney strategic operations partner Azaz Faruki. In the past, business owners used physical binders with dividers to organize their documents; these days, people might find an electronic version or template easier to use.
A QMS houses all manufacturing processes and employee training and includes details about every ingredient that touched a product. An especially important element to a QMS is a manufacturer’s device history record, which contains all documentation related to the production and tracking of the device.
A complete device history record should include a material control list, routing information and all certifications related to the product, said Chuck Hansford, director of advanced development at medical device and aerospace manufacturer Tecomet.
Manufacturing leaders should make it a habit to track, certify, date and train employees on every single material and device that is used to manufacture a final product.
Such thorough recordkeeping came in handy during an audit eight years ago, Hansford, said, when he worked for a manufacturer of implants. The customer whose design the implant maker was manufacturing had done a poor job of keeping documentation, but their own diligent recordkeeping saved the company from an FDA notice.
“We had everything. I mean, we even had letters from the OEM to show that we built their products per their requested requirements,” Hansford said.
The FDA spokesperson confirmed that not including written documentation of procedural responsibilities related to quality control is one of the common deficiences found during surveillance inspections.
To avoid these pitfalls, Hansford recommends that manufacturers make mock inspections a regular part of their year.
Tecomet has specific people within its internal quality system that regularly facilitate complete simulations of audits. At any given simulation, a facilitator might request to see where the team keeps its files or check whether documents are organized under the correct date, number or name.
“They're harder actually in most cases than the auditors themselves,” Hansford said.
What happens during a surveillance inspection?
If you are a U.S.-based manufacturer, FDA surveillance inspections usually happen without little to no notice.
In the midst of such spontaneous visits, manufacturers should remember basic protocols, such as appointing a staff member to be the primary in-person contact for the FDA auditor and ensuring all workers adhere to day-to-day safety protocols, Faruki said.
“Sometimes people believe that they don’t need to put a hairnet on, but that's a violation, and that's gonna get you dinged,” Faruki said, adding that manufacturers should make any visiting inspector adhere to the same basic principles as their staff on-site. “That person's a visitor, and they need to adhere to the same policies and guidelines.“
During an inspection, the facility should additionally be prepared to answer questions regarding the types of products made on-site, responsibilities of various personnel, the types of trainings conducted at the facility and additional compliance program items, according to the FDA spokesperson.
The length of inspections can vary depending on the size of the inspected facility, number of unit operations performed at the site and number of significant observations made during the inspection. Audits can last anywhere from several hours to multiple days. For instance, Hansford said that for one inspection in which a single product was reviewed, the audit lasted four hours.
What can happen following an inspection?
Hansford noted that every manufacturer should expect to receive “inspectional observations” after an audit.
An observation doesn’t necessarily mean that something was found to be faulty or in noncompliance on-site, but can mean the inspector found a process or other aspect of the site that can be improved, Hansford added.
“Your firm can and should respond to the [inspectional observations] during the discussion with the investigator,” according to agency guidance. “In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the investigator are regarded as positive indications of your concern and desire to voluntarily correct discrepancies.”
If the company receives a notice of noncompliance, Faruki said that it’s helpful to suggest mitigation measures while inspectors are still present, as well as the steps your organization has already taken to stay compliant.
“If you go through the mitigation measures you've identified already, and what you're doing to close that gap — there may be some flexibility to at least show the rigor of what you're trying to do as an organization,” Faruki added.
When it comes to inspections, Hansford insists that “if you have nothing to hide, you have nothing to worry about.”
