Don’t Come Around Here No More: A Drug Company Receives a Warning Letter for Limiting Inspection

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In the “what were they thinking department,” a drug company located outside of the United States recently received a Warning Letter for limiting and refusing an FDA inspection. In addition, the agency placed the company on an Import Alert, not allowing the company’s products to be imported into the United States. Tom Petty and the Heartbreakers’ 1985 hit, “Don’t Come Around Here No More,” and the weird Alison in Wonderland video come to mind.

According to the Warning Letter, the company barred access to the quality control laboratory, directing “employees to stand shoulder-to-shoulder, barring our investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution.” The company also refused to provide copies of complaint records. Finally, the investigator tried to take pictures of a piece of equipment used to manufacture the drugs, but the company official “impeded the inspection by preventing our investigator from photographing this piece of equipment.”

AGG Observations

  • A company should have procedures to handle inspections and not allow an investigator to roam unattended. However, FDA is allowed to review and copy those records concerning product manufacture, distribution, and handling. There are limits to FDA’s reach, such as access to pricing data but, in general, if the inspection or inquiry relates to quality-related concerns, FDA is entitled to access and will have the better argument if its inspection authority is challenged.
  • Barring or impeding an FDA inspection of areas where the agency is allowed to inspect is a prohibited act.
  • The issue of FDA taking photographs is more tricky. FDA believes it is allowed to take photographs, citing two court cases, but in our opinion neither one is directly on point. We recommend that companies make clear the reason photocopying in the plant is not allowed in the company’s standard operating procedures. In addition, firms should publicize and post a “no photos” policy at a facility. While an FDA investigator can disagree and insist, the investigator will frequently relent or at worst, ask for the name of the attorney who represents the company so that a follow-up discussion can occur. We cannot tell from the Warning Letter referenced above whether the company had such a policy or whether the investigator ignored a request not to photograph.
  • For companies or sites outside of the United States, there is no express statutory provision that permits FDA to inspect. However, the agency can detain or issue an Import Alert if it believes that an imported product “appears” to be unlawful. Thus, if FDA cannot inspect a facility to ensure compliance, it can tell a company that it does not have adequate assurances that the imported product is acceptable and, in an abundance of caution, detain the product. So, an ex-U.S. company normally allows the FDA inspection.
  • It is important that companies know their rights during an inspection and be trained accordingly. A firm is not required to give an investigator the keys to the facility and then leave the investigator with unfettered access. However, FDA has statutory authority to inspect facilities and review records, with limitations. Each company must balance the benefits and risks of restricting FDA access versus being cooperative. If a company decides it does not want (or is not required) to provide an FDA investigator with certain information, it is must be confident it is right on the law and consider alternatives to satisfying FDA’s request. An uncooperative company will often find itself the subject of a larger inspection, a Warning Letter, or both. On the other hand, an overly cooperative company that does not know FDA’s inspectional boundaries might be unduly harming itself through voluntary disclosure of information that FDA by law is not entitled to receive or review.
  • Procedures, training and a knowledge of the law are essential. But telling FDA “don’t come around here no more” is ill-advised.

To review the entire document and formatting for this alert (e.g., footnotes), please access the original below:

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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