Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm381538
Timestamp: 2019-02-20 09:07:40
Document Index: 471134530

Matched Legal Cases: ['§ 321', '§ 351', 'art 820', 'art 820', '§ 352', '§ 360', 'art 803', 'art 803']

Mega Electronics Ltd. 1/9/14
Dear Mr. Remes:
During an inspection of your firm located in Kuopio, Finland, on August 26, 2013, through August 29, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the FemiScan Home Trainer Incontinence Device and the ME6000 Biomonitor Device. 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 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your firm’s response, dated September 10, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm’s CAPA procedure, as outlined in the quality manual document DRAFT L-001-2.12 Laatukäsikirja, Quality Manual Mega Electronics Ltd, does not include requirements for analyzing quality data in order to identify existing and potential causes of nonconforming products, or other quality problems.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided revised CAPA procedure number L-001-2.12 Laatukäsikirja, Quality Manual Mega Electronics Ltd, which includes requirements to document all CAPA activities. Your firm also revised CAPA form number Lomake-002-Cxxxxx. Your firm indicated that the revised procedure requires analysis of quality data in that, whenever customer feedback is documented, the Quality Engineer (b)(4), the feedback will be evaluated to see if a CAPA is necessary. However, your firm did not provide a rationale as to why such data analysis method is appropriate nor the procedure to identify what other quality data will be analyzed, including the methods for such analysis. Your firm did not provide documentation indicating whether it has conducted or plans to conduct a review of all CAPA records to ensure that all required information was documented, and actions it may take based on such reviews. Further, your firm did not indicate whether all required employees were trained on the revised procedure.
a. CAPA number C13004 documented (b)(4). Upon the FDA investigator’s request for the associated complaint record, your firm’s Quality Engineer indicated that the issue directly went to CAPA and that there was no entry of the incident on the feedback log.
b. Section 9.2 of document number L-002-2.5 Myynti ja markkinointkäsikijra, Quality Manual Mega Electronics Ltd Sales and Marketing Manual, defines a complaint as a written, electronic, or oral communication that alleges deficiencies. However, section 9, Customer Feedback, of the same document does not instruct or refer to the process to be followed for documenting oral complaints.
c. According to section 9.3 of document number L-002-2.5 Myynti ja markkinointkäsikijra, Quality Manual Mega Electronics Ltd Sales and Marketing Manual, customer feedback is recorded on a (b)(4) form and a determination is made whether the feedback is a complaint. However, the form does not contain an entry or criteria for complaints to be evaluated for Medical Device Reportability. Your firm’s Quality Manager indicated that such evaluation is performed by the Quality Engineer and recorded on the CAPA form for the complaint if a CAPA is opened.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided revised customer feedback procedure number L-002-2.6 Myynti ja markkinointkäsikijra, Quality Manual Mega Electronics Ltd Sales and Marketing Manual. This procedure states that, when oral feedback is received, the customer will be instructed to submit feedback in a written or an electronic format. Also, if feedback is urgent, it will be written down by the receiver and additional information will be requested in written format. These criteria are inadequate because oral feedback that meets the definition of a complaint is to be documented upon receipt. Additionally, the procedure does not describe what type of customer feedback is considered urgent.
Moreover, your firm provided a revised form number Lomake-041-2.1, Feedback and Issue Log template, which requires documentation of whether a complaint requires medical device reporting (MDR). However, the procedure does not describe or refer to the process used to determine when a complaint should be submitted as an MDR. Your firm did not provide any documentation indicating whether it has evaluated or plans to evaluate all complaint records for MDR reportability and file MDRs where required. Further, your firm did not indicate whether all required employees were trained on the revised procedure.
3. Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, for the FemiScan device, your firm started using part number (b)(4) for component (b)(4) on June 26, 2003, and a new part number, (b)(4), was added for component (b)(4) on September 14, 2004. However, the date of approval on the BOM was not updated. Further, your firm then made a second part change and began using part number (b)(4) in lieu of (b)(4), as of December 31, 2012. This change in components was not documented, verified or validated, reviewed, and approved before implementation.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided revised design change procedure document number L-003-2.8 Tuotekehityksen Käsikirja, Quality Manual Mega Electronics Ltd Design Manual. A review of section 9 of the revised procedure indicates that it does not require design changes to be verified, or where appropriate validated, and approved before implementation. Further, your firm did not provide documentation indicating whether it has conducted or plans to conduct a review of all design changes to ensure that they are appropriately identified, documented, verified or where appropriate validated, and reviewed. Your firm did not indicate whether all required employees were trained on the revised procedure.
4. Failure to establish and maintain procedures for acceptance of incoming products, as required by 21 CFR 820.80(b). For example, your firm’s Quality Manager indicated that circuit boards are (b)(4) inspected at incoming inspection, but the results of the inspection are not recorded.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided document number L-023 1.0, Incoming Inspection Procedure, instituted in response to the observation. Section 2.1 of the procedure indicates that all incoming inspections consist of (b)(4). However, your firm did not provide any rationale as to why (b)(4). Further, the procedure did not provide or refer to the inspection procedures to be followed for components. Your firm did not provide documentation indicating whether it has conducted or plans to conduct a review of all incoming inspection procedures to ensure that they are adequate for their purposes and that the results are documented appropriately. Further, your firm did not indicate whether all required employees were trained on the revised procedure.
5. Failure to establish and maintain procedures to control all documents that are required by 21 CFR Part 820, as required by 21 CFR 820.40. For example, your firm’s CAPA form does not contain control information or any such information in order to ensure that it is the approved version for use. Further, there is no documentation to show that forms, used as part of quality system or production, are controlled.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the revised CAPA form number Lomake-002-Cxxxxx, which now contains control information. However, your firm did not provide a copy of its Document Control procedures, nor did it indicate whether it has conducted or plans to conduct a review of all documents used as part of the quality system and production to ensure they are appropriately controlled, identified, and that obsolete versions are removed. Further, your firm did not indicate whether all required employees were trained on the revised procedures.
6. Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use, as required by 21 CFR 820.250(b). For example, your firm’s Quality Manager indicated that approximately (b)(4) are sampled for incoming inspection. However, no rationale was provided as to why this is an appropriate sample size.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided document number L-023 1.0, Incoming Inspection Procedure, instituted in response to the observation. However, the procedure did not provide or refer to the sampling procedures to be followed for components. Your firm did not provide documentation indicating whether it has conducted or plans to conduct a review of all existing incoming inspection procedures to ensure that the sampling methods used are based on a valid statistical rationale. Further, your firm did not indicate whether all required employees were trained on the revised procedure.
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following: Failure of your firm to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing Paragraph 6.12‑Vigilance system, included in your firm’s documents titled, “Quality Manual, Mega Electronics Ltd (L-001-2.11 Laatukasikirja),”dated April 1, 2012, and “Quality Manual, Mega Electronics Ltd (DRAFT L-001-2.12 Laatukasikirja),”dated April 2, 2012, it was determined that the referenced documents are not MDR procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your firm submitted a revised document titled, “Quality Manual, Mega Electronics Ltd (L-001-2.12 Laatukasikirja),”dated June 9, 2013. A review of Paragraph 6.12-Vigilance system was conducted and the following issues were noted:
1. L-001-2.12 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, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions of the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1), from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
2. L-001-2.12 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:
b. There are no instructions for making MDR determinations in a timely manner.
3. L-001-2.12 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 and complete the FDA 3500A form
b. The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, and 5 day reports and the requirements for such reports
c. How your firm will submit all information reasonably known to it for each event
d. 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. L-001-2.12 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
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. 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #416124 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, Division of International Compliance Operations, Office of Compliance, Center for Devices and Radiological Health, Tel: 301-796-5587 or Fax: 301-847-8138.
Mega Electronics Ltd. - Close Out Letter 10/27/15