Inspections, Compliance, Enforcement, and Criminal Investigations
Oy Ajat Ltd 4/10/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, Maryland 20993
April 10, 2013
VIA UNITED PARCEL SERVICE
Delivery Receipt Requested
Mr. Pasi Laukka, COO
Oy Ajat Ltd.
Tekniikantie 4 B
Dear Mr. Laukka:
During an inspection of your firm located in Espoo, Finlandon October 8-11, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures solid state x-ray imagers. 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 to affect the structure or any function of the body.
Quality System Inspectional Observations
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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from you dated October 26, 2012 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
- Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that design requirements are met, as required by 21 CFR 820.30(a). For example:
a) The 420 Hardware Design Process Production procedure, section 22.214.171.124 Design Validation, does not provide information that design validation will be performed under defined operation conditions and does not address how risk analysis will be included in design validation;
We reviewed your firm’s response and conclude that it is not adequate. The response states that a risk analysis was performed for the SCAN300FP but acknowledged that the procedure did not address how the risk analysis would be included in the design validation. Your firm did not provide any updated procedures and reports that you plan to update your procedures by December 30, 2012.
b) The 420 Hardware Design Process procedure, section 126.96.36.199 Design Verification does not include requirements for verifying that the design outputs satisfy the design input requirements. The design project for the Scan 300 FPC device did not include verification showing that the design outputs satisfied the design input requirements;
We reviewed your firm’s response and conclude that it is not adequate. The response mentions that all relevant design inputs were directly or indirectly linked to one or more test performed on the product. However, your firm did not provide an updated procedure.
c) The 420 Hardware Design Process procedure states design reviews for stage P1 are to include Requirement Specifications, Business Plan, and Risk Analysis. The design review documents show that the review was conducted, but does not show that the requirements for the review topics specified in the 420 Hardware Design Process procedure were covered during the review. The review for R0, R1, and R2 were covered on June 20, 2007. The review meeting minutes did not show that a review of requirements specifications and risk analysis were reviewed during the meeting.
We reviewed your firm’s response and conclude that it is not adequate. The response states re-evaluation of the current procedures will be conducted in order to be compliant with 21 CFR820.30 but didn’t provide any updated procedures. Your firm reported that you plan to update your procedures by December 30, 2012. In addition, your firm did not provide systemic corrective action for all design control inspectional observations.
2. Failure to establish and maintain adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established requirements and to determine the effectiveness of the quality system. These quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary, as required by 21 CFR 820.22. Specifically, the firm’s internal quality audit procedure 101, does not include requirements for re-auditing deficient areas.
We reviewed your firm’s response and conclude that it is not adequate. CDRH acknowledges that procedure, “101 Quality System Audits at AJAT”, Version 1.3 dated 26.10.2012, page 4, section 5 has been updated and describes steps for conducting reaudits of deficient matters during initial internal quality audits. However, the firm did not provide systemic corrective action such as assessing previous internal audits in order to determine if a reaudit was necessary to verify corrective actions.
3. Failure to establish and maintain adequate procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. Specifically, the device history records for the Scan 300 FPC devices do not include or refer to the location of the device labeling that is used on the device.
We reviewed your firm’s response and conclude that it is not adequate. The firm provided a manufacturing document which includes instructions to print, sign and date a second copy of the serial number label. However, the document does not ensure the DHR includes or refers to the location of the primary identification label and other device labeling, such as the user manual for each production unit. In addition, a systemic corrective action is not discussed.
4. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72(a). For example calibration intervals for inspection and measuring equipment have not been established.
We reviewed your firm’s response and conclude that it is not adequate. The lack of calibration intervals was acknowledged in the response and you stated the procedure will be reviewed and modified. Your firm did not provide procedures to establish calibration intervals for inspection and measuring equipment. In addition, a systemic corrective action was not discussed.
5. Failure to establish procedures for identifying training needs to ensure that all personnel are trained to adequately perform their assigned responsibilities, and document the training, as required by 21 CFR 820.25(b).
We reviewed your firm’s response and conclude that it is not adequate. Your firm acknowledges the failure to describe in detail procedures for training and identifying training needs, but did not provide updated procedures. Your firm plans to update the procedures by December 30, 2012.
6. Failure to establish a quality plan as required by 21 CFR 820.20(d).
We reviewed your firm’s response and conclude that it is not adequate. Your firm plans to prepare a quality plan that will be compliant with 21 CFR 820.20(d), however, your firm did not provide any additional details of the quality plan.
7. Failure to establish and maintain adequate procedures for management review as required by 21 CFR 820.20(c). Specifically, the firm’s procedure 102 Improvement Work, requires management reviews to be conducted on an annual basis. There were no written procedures to ensure the quality system satisfies the requirements of the Quality System regulation.
We reviewed your firm’s response and conclude that the response appears adequate.
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to develop and maintain written MDR procedures as required by 21 CFR 803.17. Specifically, there is no procedure for reporting medical device reportable events to the FDA.
We reviewed your firm’s response and conclude that your firm’s revised version of its MDR procedure titled “601 Quality control, nonconforming product control and incident reporting”, ver. 1.3 dated October 26, 2012, is not adequate. The following issues were noted:
1. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a) The procedure does not reference a process for identifying and evaluating events occurring outside the United States (U.S.) as potentially reportable to FDA. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that is the same or similar to a device that has been cleared or approved for marketing in the U.S. By not considering events that occur outside of the U.S., potentially reportable MDRs may not be identified and evaluated for MDR decision making and submission to FDA as required by 21 CFR 803.50 and 21 CFR 803.53. For example, Section 3.3 “FDA Medical Device Reporting (MDR)” of your firm’s MDR procedure limits reporting of MDRs to products sold to or delivered to the US.
b) There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
2. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
a) There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b) There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
c) The procedure does not specify who makes the decision for reporting events to FDA.
3. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a) Instructions for how to obtain the FDA 3500A form.
b) Circumstances under which an event must be submitted as a 30-calendar day or 5-day report.
c) How your firm will submit all information reasonably known to it for each event.
d) The circumstances under which your firm must submit initial, supplemental or follow-up reports and the requirements for such reports.
e) The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
4. The procedure does not describe how your firm will address documentation and record-keeping requirements, including:
a) Documentation of adverse event related information maintained as MDR event files.
b) Information that was evaluated to determine if an event was reportable.
c) Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d) Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
In addition, Section 3.3 of the procedure includes a reference to baseline reporting, which are no longer required. We recommend that all references to baseline reports be removed from your firm’s MDR procedure (see 73 Federal Register Notice 53686, dated September 17, 2008).
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
U.S. federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, RM 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #394115 when replying. If you have any questions about the contents of this letter, please contact William Jung at (301) 796-6228.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Alberto Gutierrez, PhD
Office of In Vitro Diagnostics and
Radiological Health (OIR)
Center for Devices and