Agency cites device classification disputes, inadequate manufacturing controls, and quality system deficiencies dating back to 2011
An August 26, 2026, FDA warning letter to Peter Schiff Enterprises, a Tennessee manufacturer of cardiac devices, describes a troubling combination of regulatory violations, inadequate quality controls, and deficiencies that have persisted through multiple FDA inspections.
The company manufactures cardiac fibrillators and electrode pads used during cardiac surgery, including procedures involving critically ill patients and children undergoing congenital heart defect repairs.
FDA identified concerns involving the devices’ regulatory classification, design modifications, manufacturing materials, complaint handling, corrective and preventive action (CAPA), and other fundamental quality management requirements.
Perhaps most concerning, several violations were identified as repeat observations from FDA inspections conducted in 2011, 2013, and 2017.
Device classification and design changes
One of FDA’s principal concerns involved the company’s Model 310C cardiac fibrillator. Peter Schiff Enterprises maintained that the product was an unclassified preamendment device, originally introduced before the Medical Device Amendments of 1976.
However, FDA determined that the device had undergone significant modifications since its original introduction in 1966. These included replacing mercury batteries with a lithium battery, changing electrical output specifications, modifying electrode placement, and transitioning from analog to digital technology.
FDA concluded that the cumulative changes could significantly affect the device’s safety or effectiveness, triggering premarket notification considerations under 21 CFR 807.81(a)(3).
The company also maintained that its adult and pediatric cardiac electrode pads qualified for a premarket notification exemption as electrode cables under 21 CFR 890.1175. FDA disagreed, explaining that the pads were intended to connect a fibrillator to cardiac tissue rather than connect electrodes to diagnostic equipment.
The agency recommended that the company submit a Section 513(g) Request for Information to obtain a formal determination of the devices’ appropriate regulatory classification.
Manufacturing and patient safety concerns
Beyond device classification, FDA documented substantial deficiencies in manufacturing and quality controls. Investigators identified materials used in electrode pad manufacturing that lacked adequate specifications, supplier qualification, and documented acceptance criteria.
Of particular concern, some silicone materials carried safety data sheet warnings indicating that they were not intended for internal or medical use.
FDA also determined that the company had not completed an adequate biocompatibility assessment to evaluate potential patient risks. Other findings included inadequate design controls, undocumented rework of rejected electrode pads, incomplete production records, and finished devices released without required inspections.
For products used in cardiac surgery, these deficiencies raise significant concerns about device reliability and patient safety. FDA identified potential consequences including tissue damage, inflammatory reactions, and device performance failures that could interfere with surgical procedures.
Complaints, CAPA, and repeated violations
The warning letter also describes deficiencies in the company’s processes for identifying, investigating, and correcting product problems. According to FDA, the company’s owner acknowledged receiving customer feedback about fibrillator batteries failing to start. However, this information had not been documented as complaints.
FDA also found that the company’s complaint handling procedure lacked essential requirements for evaluating complaints, conducting investigations, and determining whether events required reporting under FDA’s Medical Device Reporting regulations.
The CAPA findings were particularly significant. FDA determined that the company had failed to adequately investigate nonconformities and document corrective actions. In one example, the company had not documented an adequate review demonstrating the effectiveness of a corrective action involving sterilization validation.
FDA identified CAPA deficiencies as repeat observations from inspections conducted in 2011, 2013, and 2017.
Other longstanding deficiencies included inadequate internal audits, management reviews, and device history records. According to the warning letter, the company had not conducted internal quality audits or management reviews despite having operated since 1966.
These findings illustrate why an effective quality management system requires more than written procedures. Manufacturers must implement their processes, evaluate results, investigate deficiencies, and verify that corrective actions prevent problems from recurring.
Additional reporting and traceability violations
FDA also identified failures involving Medical Device Reporting (MDR) and Unique Device Identification (UDI). The company lacked written MDR procedures, a deficiency FDA identified as a repeat observation from its 2011 inspection.
The agency also found that the devices lacked required unique device identifiers and that the company had not submitted the necessary information to FDA’s Global Unique Device Identification Database (GUDID). Those requirements support the identification, traceability, and postmarket monitoring of medical devices.
A warning letter across two quality system regulations
The timing of this enforcement action introduces another important regulatory consideration. FDA inspected the company in December 2025, when the former Quality System Regulation was still in effect.
However, the Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference, became effective on February 2, 2026.
FDA explicitly stated that although the inspection was conducted under the former regulation, any corrective actions proposed or implemented must comply with the QMSR requirements now in effect.
This distinction is important for manufacturers responding to inspection findings that originated before the QMSR implementation date.
FDA requests independent quality system audits
Given the extent of the findings, FDA requested that Peter Schiff Enterprises obtain an independent expert assessment of its manufacturing and quality assurance systems.
The agency requested an outside consultant’s audit report and management certification that the report had been reviewed, and necessary corrections initiated or completed. Initial certifications are due February 26, 2027, with subsequent certifications requested in 2028 and 2029.
FDA also directed the company to respond to the warning letter within 15 business days of receipt and warned that failure to adequately address the violations could result in additional regulatory action.
The larger regulatory lesson
The Peter Schiff Enterprises warning letter illustrates how regulatory compliance problems can extend far beyond an individual device classification dispute.
Changes to device design can introduce new risks and premarket submission requirements. Inadequate supplier controls and manufacturing processes can compromise product quality. Weak complaint handling can prevent manufacturers from recognizing emerging problems. And ineffective CAPA systems can allow deficiencies to persist across multiple inspections.
Most importantly, repeated inspection findings raise questions about whether a manufacturer’s quality management system is capable of identifying and correcting its underlying problems.
The warning letter does not establish that the devices have caused patient injuries. It does, however, document FDA’s concerns about risks associated with the identified deficiencies.
For medical device manufacturers, the essential lesson is that regulatory compliance is not demonstrated simply by maintaining procedures or responding to inspection observations. It requires an effective quality management system that identifies risks, investigates problems, implements corrective actions, and demonstrates sustained improvement.
