Inspections, Compliance, Enforcement, and Criminal Investigations
R4 LLC 5/11/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
May 11, 2009
VIA FEDERAL EXPRESS
William F. Zimmerman
Chairman and CFO
17999 Foltz Parkway
Strongsville, OR 44149
Dear Mr. Zimmerman:
During an inspection of your firm located in Strongsville, OH, on March 11 through 23,2009, an investigator from the United States Food and Drug Administration ("FDA") determined that your firm is the manufacturer of medical device software, called the R4 Acert perinatal reporting software, which works in conjunction with an ultrasound machine to upload images, collect data, calculate measurements, and run reports. Under section 20l(h) of the Federal Food, Drug and Cosmetic Act (the "Act"), 21 U.S.C. § 32l(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that the medical devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained. [21 CFR § 820.20] Specifically:
(a) Quality system procedures have not been established. [21 CFR § 820.20(e)] For example, there are no written corrective and preventive action procedures, design change control procedures, complaint procedures, and medical device reporting procedures.
(b) No employees in your firm are familiar with the requirements of 21 CFR Part 820 and no one has received training on the Quality System Requirements.
2. Failure to establish procedures for implementing corrective and preventive actions; and failure to document corrective and preventive activities, including analysis of quality data sources, investigations of causes of nonconformances, and implementation of corrective and preventive actions. [21 CFR§ 820.100]
Specifically, your firm has not developed corrective and preventive action procedures. Additionally, your Director of Application Development stated that there is no formal trending of the customer call log to identify any existing and potential causes of nonconforming product or other quality problems.
3. Failure to establish complaint handling procedures for receiving, reviewing, and evaluating complaints; and failure to document the evaluation of complaints. [21 CFR § 820.198(a)]
Specifically, your firm has not developed a complaint handling procedure to assure all complaints are documented, evaluated, and if necessary investigated. Additionally, complaint investigations are not fully documented.
4. Failure to establish design change control procedures for the identification, documentation, validation and/or verification, review, and approval of design changes before implementation. [21 CFR § 820.30(i)]
5. Failure to establish and maintain a design history file that demonstrates the design was developed following the design control requirements of21 CFR P31i 820. [21 CFR § 820.30(j)]
Specifically, since purchasing the 51 O(k) for the R4 software your firm has released two versions of the R4 Acert perinatal reporting software (version 4.10 and 4.15) and you have not specified what documents must be created and maintained as part of the design change.
6. Failure to perform a risk analysis for the R4 Acert perinatal reporting software. [21 CFR § 820.30(g)]
7. Failure to include the signature of the approving official for documents.[21 CFR § 820.40(a)]
Specifically, your firm creates and stores all written information as electronic files and you do not keep any hard copies of these records. Your electronic documentation system does not meet system validations, system access limitations, audit trails, signature manifestations, and signatures to record linking requirements to ensure they are trustworthy, reliable and generally equivalent to paper records as required by 21 CFR Part II.
The inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to develop written Medical Device Reporting procedures as required by Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR 803.17.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in the initiation of regulatory action without further notice. This may include, but is not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to Correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions yon have taken. If your p1mmed corrective actions will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by the FDA. The specific violations noted in this letter and in the FDA 483s may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt action to con-eel the violations and to bring your products into compliance.
Teresa C. Thompson