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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ophthalmic Technologies, Inc. 25-Mar-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Center for Devices and Radiological Health
9200 Corporate Blvd
Rockville, MD 20850


MAR 25 2008

WARNING LETTER

VIA FEDERAL EXPRESS AND FACSIMILE

Mr. Richard Weitz
President
Ophthalmic Technologies, Inc.
37 Kodiak Crescent, Unit 16,
Toronto, Ontario M3J3E5, Canada

Dear Mr. Weitz:

During an inspection of your firm located in Toronto, Ontario, Canada on July 30, 2007 through August 2, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Ophthalmic Technologies Inc. (OTI) Scan 1000, OTI Scan 2000, and OTI OCT/SLO combination imaging system. Under section 201(h) of the Federal Food. Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (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.

Quality System Regulation Violations
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 a response from your firm dated August 28, 2007, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that 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. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA) that include requirements for verifying or validating corrective and preventative actions to ensure that the action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, your firm's CAPA Procedure, Document No. (b)(4) fails to require validation or verification of corrective and preventive actions and your firm failed in fact to verify or validate corrective and preventative actions for effectiveness with respect to CAPAs (b)(4) and (b)(4).

The adequacy of the response cannot be determined at this time. Your firm has not indicated what measures it has taken or plans to take to require verification or validation of its corrective of preventive actions to ensure effectiveness of the action and that the action does not adversely affect the finished device.

2. Failure to establish and maintain procedures for implementing corrective and preventative actions that include requirements for identifying the action needed to correct and prevent recurrence of the nonconforming product and other quality problems, as required by 21 CFR 820.100 (a)(3). In compliance with this regulation, your firm's CAPA Procedure requires (b)(4). However. your firm failed to adequately implement this procedure. For example, CAPAs (b)(4) and (b)(4) do not sufficiently identify the actions needed to correct and prevent recurrence of the problems.

The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation of implementation of procedures requiring the identification of necessary corrective and preventative actions.

3. Failure to establish and maintain procedures for implementing corrective an d preventative actions that include requirements for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR 820.100(a)(5). For example, your firm's CAPA Procedure fails to require procedure review and approval, so that methods and procedures may be modified to correct the identified quality problems.

The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation of the additions to be made to its CAPA Procedure to require implementation of changes in methods and procedures to correct quality problems.

4. Failure to maintain complaint files, establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, failure to establish procedures to ensure all complaints are processed in a uniform and timely manner, failure to establish procedures to ensure oral complaints are documented upon receipt, and failure to establish procedures to ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under Title 21, CFR, part 803, Medical Device Reporting, as required by 21 CFR 820.198. For example, none of the documents your firm provided (Complaint Files Procedure, Document No: (b)(4) (b)(4) Document No.:(b)(4) and (b)(4) include procedures for investigating, evaluating, and reviewing device malfunctions, failures to meet specifications, and events reportable to FDA under part 803, or procedures for documenting decisions not to investigate complaints.

Your firm also failed to implement the few inadequate procedures that it does have in place. For example you failed to establish and maintain a (b)(4) as required by (b)(4) of your (b)(4) Procedure. As a result, your firm failed to document the nature and details of the complaints it received. Your firm also failed to evaluate the importance of complaints, or provide records of minutes of review, as required by (b)(4) Procedure (b)(4).

The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation of the modified complaint handling procedure for receiving, reviewing, and evaluating complaints, including evidence of procedure implementation.

5. Failure to review, evaluate and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications and failure to maintain a record that includes the reason no investigation was made, as required by 21 CFR 820.198(b) and (c). For example, your firm failed to investigate the complaints filed on (b)(4) and (b)(4) or provide a record indicating the reasoning behind this decision.

The adequacy of the response cannot be determined at this time because your firm has not indicated what measures it has taken or plans to take to prevent these violations from recurring in the future.

6. Failure to establish and maintain procedures for acceptance of incoming product and failure to inspect, test or verify incoming product as conforming to specified requirements, as required by 21 CFR 820.8 0(b). For example, your firm fails to have any procedures in place for the inspection or testing of incoming product upon receipt, for the verification of incoming product as conforming to your specifications, or for the handling of rejected product. As a result, your firm accepted several components that failed to meet both your own specifications and those of the supplier. The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation indicating that you have developed or implemented procedures for the inspection, testing, and verification of incoming product.

7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C'FR 820.22. For example, your firm has failed to conduct quality audits to verify that the quality system is effective in fulfilling the firm's quality system objectives. Though your firm does have an Internal Audits Procedure, Document No. (b)(4) your firm has failed to implement it, as quality audits are not being conducted as specified in the procedure. For example:

A. Your firm has failed to establish a quality audit program with (b)(4)as required by Internal Audits Procedure sections (b)(4)
B. Your firm has failed to generate comprehensive audit reports indicating the condition of the process audited, as required by Internal Audits Procedure section; and
C. Your firm has failed to (b)(4) as specified (b)(4)

The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation of established procedures for quality audits, measures taken to ensure that internal audits will be conducted in compliance with quality system requirements, or that comprehensive audit reports will be maintained as specified in the procedure and that the reports will indicate the condition of the process audited.

8. Failure of management to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives, and failure to document dates and results of quality system reviews, as required by 21 CFR 820.20(c). Although your firm has management review procedures in place, titled "Management Review Process". document number (b)(4) and (b)(4), document number (b)(4) effectiveness (b)(4), your firm has failed to implement them. For example, your firm has failed to conduct (b)(4) reviews, as required by section (b)(4) reviews as required (b)(4) of the Management Review Process. Additionally, the management failed to (b)(4) as required by section (b)(4) of your (b)(4) Procedure.

The adequacy of the response cannot be determined at this time because your firm has failed to submit documentation of quarterly management review proceedings and has not indicated what measures it has taken or plans to take to prevent these violations from recurring in the future.

9. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm fails to have any procedures in place for identifying training needs and fails to train its employees regarding any quality system procedures, including device testing and release.

The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation of implementation of a training program in quality systems for all employees.

Medical Device Reporting, Regulation Violations

Our inspection also revealed that your firm failed to establish Medical Device Reporting (MDR) procedures for your OTI Scan 1000, OTI Scan 2000, and OTT OCT/SLO combination imaging system, as required by 21 CFR 803.17. Significant deviations include, but are not limited to, the following:

Failure to develop, maintain, and implement written MDR procedures for internal systems that provide for: (1) timely and effective identification, communication, and evaluation of events that are subject to MDR requirements, (2) a standardized review process for determining when an event meets the criteria for reporting, and (3) timely transmission of complete medical device reports to FDA and/or manufacturers, as required by 21 CFR 803.17(a)(1). Section (b)(4) of your firm's (b)(4)b) does require (b)(4) and states that "the health and (b)(4)." However, this document fails to establish a process for the timely review and evaluation of adverse events against FDA's reporting criteria or the timely transmission of reports to FDA.

The adequacy of the response cannot be determined at this time. Your firm failed to submit documentation of revisions made to your procedures to bring them into compliance with MDR requirements.

Given the serious nature of the violation(s) of the Act, OTI Scan 1000, OTT Scan 2000, and OTI OCT/SLO combination imaging system manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated and misbranded and the methods used in, or the facilities or controls used for, their manufacture appear not to conform with Good Manufacturing Practices. 21 U.S.C. 381(a)(1) & (a)(3). As a result, FDA has issued an Import Alert, notice of which you will be receiving shortly, whereby FDA may refuse admission of these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from this Import Alert, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter for which you have not already provided an adequate response. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.

Also, U.S. 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 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 occurring again. 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. Please provide a translation of documentation not in English to facilitate our review.

Your response should be sent to: Ronald L. Swann, Chief, Dental, ENT, and Ophthalmic Devices Branch, HFZ-331, 9200 Corporate Boulevard, Rockville, Maryland, 20850, USA. If you have any questions about the content of this letter please contact: Ronald L. Swann at 240-276-0115 or 240-276-0114.

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 Inspectional Observations, Form FDA 483 (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,

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

Cc: Mr. Jon Schnaars
Ophthalmic Technologies, Inc.
120 Godwin Avenue,
Ridgewood, New Jersey, 07450