Recipient:iScreen, LLC
Product: Class II ophthalmic camera
Date: 10/2/2007
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.
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.
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.
FDA New Orleans District Office
