Inspections, Compliance, Enforcement, and Criminal Investigations
iScreen, LLC 02-Oct-07
Department of Health and Human Services
Public Health Service
New Orleans District
October 2, 2007
WARNING LETTER NO. 2008-NOL-02
Mr. Jack R. Bellows, President
3181 Poplar Avenue, Suite 200
Memphis, Tennessee 38111
Dear Mr. Bellows:
During an inspection of your firm, located at 3181 Poplar Avenue, Suite 200, Memphis, Tennessee on July 24 - 25, 2007, an investigator from the United States Food and Drug Administration (FDA) determined your firm is the specification developer for a Class II ophthalmic camera. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 321(h)], this product is a 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 is intended to affect the structure or function of the body.
This inspection revealed your ophthalmic cameras are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], in 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, Part 820 (21 CFR 820). We received a response from you dated September 18, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, which was issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. You have not established or implemented written procedures for performing corrective and preventive actions (CAPA). In addition, your firm does not document or conduct CAPA activities such as trend analysis of sources of quality data, investigations of causes of nonconformities, or the actions needed to prevent recurrence of nonconforming product [21 CFR 820.100(a)].
For example: Your firm was aware the laptop computers and iScreen cameras eventually would have problems communicating with each other and made the decision to only upgrade the software for individual devices as customers began to experience problems with the devices. You performed corrective action following complaints but did not make an effort to prevent the same complaints for all customers prior to problems occurring.
We have reviewed your response and have concluded it is inadequate because you did not include a copy of your CAPA procedures for our review. Therefore, we cannot determine if the instructions for the completion of the Complaint Report form, the documentation of the investigation of the cause of the reported problem, and the nature of repair and prevention of the problem noted are adequate.
2. You did not establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation [21 CFR 820.30(i)].
For example: You changed the software which controls the user interface program and digital and analog cameras for the iScreen ophthalmic camera to a new version, version and were unable to provide any documentation to show validation or verification procedures were conducted prior to installing the program into all of your systems.
We have reviewed your response and have concluded it is inadequate because you did not include a copy of your design control procedures for our review. Without this information and examples of their use, we are unable to determine whether your procedures for the documentation of validation and verification are adequate.
3. Your device master records (DMR) failed to include or refer to the location of all installation, maintenance, servicing, packaging, labeling, process and quality assurance procedure specifications (21 CFR 820.181).
For example: The "Engineering Drawing of the Device" originally provided to the contract manufacturer of the ophthalmic camera did not include most of the required specifications, such as labeling and software changes.
We have reviewed your response and we have concluded it is inadequate because you did not include a copy of the complete DMR for our review.
4. You have not established and maintained procedures to ensure device history records (DHR) for each lot or unit are maintained to demonstrate the devices are manufactured in accordance with the DMR and the requirements of the QS regulation (21 CFR 820.184).
For example: You maintain a rotating inventory of devices in which devices are repaired and routinely redistributed to other customers, as needed, and you do not maintain a complete device history which includes all specifications, service history, and acceptance and release activities for each device.
We have reviewed your response and we have concluded it is inadequate because you did not include an example of a completed DHR. In addition, the blank DHR did not include space for details regarding the service/repair of each unit nor was an example of labeling attached.
5. You have not established, maintained, and implemented procedures for receiving, reviewing, and evaluating complaints to ensure complaints are processed in a timely manner; oral complaints are documented upon receipt; complaints are evaluated to determine whether an investigation is necessary; and complaints are evaluated to determine whether the incident represents a Medical Device Reporting (MDR) reportable event. Also, you do not maintain complete complaint files [21 CFR 820.198(a)].
You use a "Device History" form to document customer complaints. Review of complaints from 2005 to 2007 revealed all records were missing information required to meet the quality system complaint handling requirements. These discrepancies included, but were not limited to the following: failure to include contact information for complainants; failure to document investigation activities; failure to document corrective actions taken; and, failure to evaluate whether the complaint might be an MDR reportable event.
We have reviewed your response and we have concluded it is inadequate because you did not include a copy of the complaint procedures for our review.
6. You have not established and implemented procedures to control all documents required by the QS regulation. Your firm has not established document control procedures to track changes to documents to ensure only the most current versions are being used. Your documents do not include effective dates, revision numbers, or any documentation to show the record has been reviewed and approved for use in your firm (21 CFR 820.40).
For example: Your DMR did not include a date and was not signed by anyone to show it was an approved document for use in the firm. A review of your hard copy product manual and instructional CD for your ophthalmic camera revealed the same deficiencies.
We have reviewed your response and we have concluded it is inadequate because you did not include a copy of your document control procedures and at least one example of a controlled/approved document for our review.
Our inspection also revealed your devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2), since your firm failed or refused to furnish material or information with respect to the device which is required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR 803 - MDR regulation. Significant deviations include, but are not limited to, the following:
1. You failed to develop, maintain and implement written MDR procedures (21 CFR 803.17).
We have reviewed your response and we have concluded it is inadequate because you did not include a copy of your new MDR procedures for our review. In addition, the Complaint Report form included in your response does not provide space for documentation of the investigation of the reason for the complaint or the identification of the individual unit involved.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are 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 they may take this information into account when considering the award of contracts. Additionally, premarket approval 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 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 an explanation of how you plan to prevent these violations, or similar violations, from recurring. 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 corrections will be completed.
Your response should be sent to the U.S. Food and Drug Administration, Attention: Cynthia R. Gibson, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Ms. Gibson at (251) 344-8208, extension 105.
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 FDA. The specific violations noted in this letter and in the Inspectional Observations, Form 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 bring your products into compliance.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483