| Public Health Service Food and Drug Administration |
| Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
Department of Health and Human ServicesAugust 31, 2010
Ref: 2010-DAL-WL-14
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mark L. Stribling, President and CEO
iVu Imaging Corporation
4121 Grace Lane
Grapevine, Texas 76051
Dear Mr. Stribling:
During an inspection of your firm located at the above-referenced address on February 24 and 26, 2010, March 29 through 31, 2010, and April 1, 2010, investigators from the United States Food and Drug Administration (FDA or Agency) determined that your firm manufactures Sofia™ Automated Tomographic Ultrasound (ATUS) Imaging System. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), this product is a medical device because it is 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 any function of the body.
This inspection revealed that these 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, their manufacture, 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.
We received your firm's response from Mr. Mark R. Rogers, Vice President of Operations, dated April 8, 2010, to our investigators' inspectional observations. Mr. Rogers responded that the inspectional observations identified GMP nonconformances in your firm's manufacturing process and that your management intended to complete corrective actions within 90 days. We acknowledge your firm's commitment to meeting all regulatory requirements established by the FDA for medical device manufacturers. However, we consider your firm's response incomplete as your firm's response has neither explained nor provided specific corrective actions to resolve each of the noted inspectional observations. We have not received your further response after 90 days. Please provide us an update of your firm's corrective actions and your accomplishment since the April 8, 2010 response. The Agency may conduct follow-up inspections to assure that your firm's corrections are adequate.
At the conclusion of the Inspection, the investigators issued to you the Form FDA-483 (List of Inspectional Observations) which identifies a number of significant violations including, but not limited to, those described below.
Quality System Violations
1. Failure to establish and maintain procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses. The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate, and the design validation results must be documented, as required by 21 C.F.R. § 820.30(g). FDA 483 Items 3, 4, and 5. Specifically:
a. Several validation (functional) tests in Design Phase IV were not completed (i.e., (b)(4) Test, (b)(4) Test (b)(4) and (b)(4) Tests, (b)(4) Test, and (b)(4) Test).
b. The (b)(4) Test did not specify specific criteria for accepting or rejecting ((b)(4) phantom breast images acquired. This test documented that an acquisition of ((b)(4)) frames (images) was successful. It did not define what "successful" means or the quality of the images to detect and differentiate hyper and hypo echoic lesions.
c. The (b)(4) Test was conducted on a phantom breast of a nominal size. The test protocol did not explain why other cup sizes were not tested in order to access the ability and limitation of the ultrasound system to detect and differentiate lesions in the smallest and largest cup sizes.
d. The design was not validated using production units or their equivalents. The test report (No. 3135042DAL-001) indicated that electrical testing was conducted on a prototype unit on or before April 30, 2008. Your firm stated to the investigator that the manufacturing process has not significantly changed from the prototype. unit to the current production units. Your firm could not provide supporting documentation to demonstrate that the design and production process and specifications of the prototype unit are equivalent to that of the subsequent production units.
2. Failure to establish and maintain procedures to ensure that the device history records (DHR) for each batch, lot, or units are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 C.F.R. § 820.184. FDA 483 Item 1(a) and (d). Specifically:
a. Your firm did not verify device serial numbers for accuracy and maintain copies of the product labels in the device history records (DHR) before distributing the devices. For example, the performance check records documented the same serial #(b)(4) for the two separate ultrasound imaging systems installed at two separate user sites on January 29, 2009 and May 4, 2009, respectively.
b. Your firm did not maintain in the performance check records (DHR) all (b)(4) images acquired and tested during the final assembly and testing of the ultrasound imaging systems as required by the Performance Check Procedure, FCD-0158, Revision A.
3. Failure to document the results of installation, inspection, and any required testing in accordance with the manufacturer's instructions and procedures to demonstrate proper installation of the device, as required by 21 C.F.R. § 820.170(b). FDA 483 Item 1(e). Specifically:
Your firm's installation checklist did not document nor attach the results of installation of the ultrasound system units installed at the user sites on August 26, 2008, October 15, 2008, January 29, 2009, and May 4, 2009.
4. Failure to establish and maintain device master records (DMRs) to include or refer to the location of device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 C.F.R. § 820.40, as required by 21 C.F.R. § 820.181. FDA 483 Item 6. Specifically:
Your firm's device master record (DMR) was not complete at the time of the inspection. Your firm confirmed to the investigators that it had a draft DMR and was still working with the contract manufacturer to develop additional acceptance procedures for the transducer, ultrasound console unit, motor assembly, and software.
Responding to This Warning Letter
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
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, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) deviations are reasonably related will not be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing 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 and explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include documentation of the corrective action you have taken. If your planned corrections 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 correction will be completed.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection 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 actions to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
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