When the U.S. Food and Drug Administration (FDA) comes knocking for an inspection, a company’s usual concerns revolve around compliance, spotless records, and a robust quality system. However, one detail that has increasingly drawn attention has been the FDA’s practice of taking photographs during inspections. This seemingly minor aspect recently became a flashpoint, as highlighted in a Warning Letter sent to a Chinese drug manufacturer, casting a spotlight on the broader implications for FDA-regulated industries.
Lights, Camera, Regulation
The FDA’s authority to take photographs during inspections is rooted in Section 704 of the Federal Food, Drug, and Cosmetic Act. While the statute explicitly grants the FDA the right to inspect facilities, processes, and records, the use of photography has been a point of contention for decades. Inspectors often argue that photos provide indisputable evidence of non-compliance, capturing visual snapshots of unsanitary conditions, incomplete records, or equipment issues that might otherwise be debated in text.
Companies, however, aren’t always thrilled about playing unwilling subjects in the FDA’s photo album. Common concerns include proprietary information exposure, fears of misinterpretation, or just the plain old discomfort of being caught in an unflattering moment of regulatory chaos.
Recent Fireworks: The Chinese Drugmaker Incident
In one of its recent Warning Letters, the FDA chastised a Chinese drug manufacturer for obstructing investigators by limiting their ability to photograph manufacturing areas. According to the FDA, the company delayed inspection activities, by not allowing FDA to take photographs of certain manufacturing equipment as part of the inspection. The agency took this as an outright obstruction, reminding the manufacturer that refusing or delaying an FDA inspection could lead to dire consequences, including import bans.
This wasn’t the first time the FDA tangled with a foreign manufacturer over photography. In prior cases, companies have attempted to limit photo-taking by invoking concerns over intellectual property or internal security policies. The FDA’s stance remains steadfast: if you’re producing drugs/FDA-regulated products for the U.S. market, compliance includes allowing inspectors to document what they see in your facility, camera in hand, otherwise, FDA is prepared to assess an adulteration charge for refusal of inspection.
What’s the Fuss?
While the FDA considers photography an essential part of inspections, industries see potential pitfalls:
- Intellectual Property Risks
FDA-regulated industries, especially pharmaceutical and biotech companies, are understandably protective of proprietary equipment designs, formulations, and processes. A snapshot in the wrong hands could spell disaster. - Context Matters
A single photograph could be misinterpreted. A dusty shelf might be part of a rarely accessed area, not indicative of a systemic issue. Yet, once documented, the burden of proof shifts to the company to explain the context. - Risk of Regulatory Overreach
Critics argue that FDA photography may sometimes cross into regulatory overreach. Photos could capture areas or items that are not directly relevant to the inspection, raising questions about how much evidence might be used against a company.
The Domino Effect: Implications for FDA-Regulated Industries
The FDA’s strict stance on photography, nonetheless, sends a clear signal to domestic and international manufacturers alike: transparency is non-negotiable. Here’s how this policy shakes out for various stakeholders:
- Enhanced Documentation
Companies should ensure spotless manufacturing floors, equipment, and practices at all times, as photos oftentimes speak louder than written observation. - Training and Protocol Adjustments
Employees must be trained to handle inspections where photography occurs. Developing internal policies to allow photo-taking while protecting sensitive areas will become increasingly critical. - Legal and Policy Updates
Manufacturers may need to update supplier contracts and confidentiality agreements to address the risks posed by third-party inspections with photo evidence. - Heightened Scrutiny for Foreign Facilities
The FDA’s recent Warning Letter underscores its willingness to enforce strict compliance on foreign manufacturers. This could increase delays in product approvals and supply chain disruptions if non-compliance issues persist.
A New Focus: Compliance in the Age of Photography
The FDA’s insistence on using photography during inspections is a reflection of the agency’s evolving approach to ensuring compliance. And while companies can still elect to battle it out with FDA, to help maintain a smooth inspection, we recommend inquiring with an investigator their basis for taking photos, ensuring that what they are photographing is within the scope of the inspection assignment, and taking a side-by-side photograph to discuss later, in the event the FDA photos don’t portray an accurate picture.
Nonetheless, for manufacturers in FDA-regulated industries, the moral of the story is simple: be camera-ready. This doesn’t mean rolling out a red carpet or scheduling a touch-up for the factory floor. Instead, it means fostering a culture of compliance, transparency, and readiness to ensure that when the FDA inspector comes with their camera, you’re ready to prove that you are ready for your close-up.
For more information on FDA Inspections, or for other questions on FDA compliance and enforcement, please contact us at info@garg-law.com.
