Inspections, Compliance, Enforcement, and Criminal Investigations
Moor Instruments Ltd 9/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
SEP 6, 2011
VIA UNITED PARCEL SERVICE
Mr. David Boggett
Owner and CEO
Moor Instruments Ltd.
Devon, EX13 5 DT, United Kingdom
Dear Mr. Boggett:
During an inspection of your firm located in Devon, United Kingdom,on May 3, 2011, through May 6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Laser Doppler Blood Flow Products. 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.
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 Dr. Xiabing Huang, Managing Director, dated May 13, 2011, 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:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, per 21 CFR 820.100(a).
For example: The document identified by your firm as its corrective and preventive action procedure, (b)(4) titled Change Note and Preventive Action Procedure, does not provide requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, or other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that its (b)(4) Non Conformance & Corrective Action Procedure needs an additional section or additional procedure to deal with corrective and preventive actions by analyzing trends from a range of information and generating effective preventive actions. Your firm planned to discuss the requirement at the next Management Review Meeting scheduled for 6/8/11 and committed to implement a new procedure by September, 2011, and forward a copy of the revised procedure for review. Your firm has therefore not provided any evidence of corrective actions to address this observation.
2. Failure to maintain adequate complaint files, per 21 CFR 820.198(a).
For example: procedure (b)(4) titled Customer Feedback Procedure, sections 1.1.1 - 1.1.5 require complaint forms Q11 and Q15 to be completed. Form Q15 “requires details of the nature of the complaint, the action taken and a record of when the complaint is resolved.” However, the following complaint forms were not completed:
a. Complaints # 178, 180, 183, 233, and 236 are missing information in the “Action Taken” field.
b. Complaint # 199 and 219 have no information in the “Justification for NOT raising Nonconformance” field.
c. Complaints # 198, 199, 200, 207, 208, and 209 are missing the date of resolution.
d. Complaint # 200 has only the words “solved” and “resolved” in the “Resolution” and “Date Resolved” fields, respectively.
We reviewed your firm’s response and conclude that its adequacy cannot be determined at this time. Your firm has updated and clarified several of the complaint records based on other records on hand. Several other fields not specifically cited in the FDA 483 have also been filled and clarified on the complaint forms. Your firm acknowledges that these omissions demonstrate that (b)(4) Customer Feedback Procedure is not being adhered to. Therefore, your firm is in the process of revising (b)(4) Your firm stated that the revised procedure will be complete by September, 2011, and forwarded for review. Upon completion, your firm plans to implement the procedure and re-train staff. However, your firm did not provide any evidence of implementation of its corrective actions to address this observation or documentation for the consideration of implementing a system corrective action.
3. Failure to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part including documentation of the date and signature of the individual(s) approving the document, per 21 CFR 820.40(a).
For example: (b)(4) Control of Documents Procedure, Issue 5, section 1.1.23, requires that “the person responsible for the drawing shall ensure that the drawing is completed correctly and that the drawing title, issue number, dimensions, tolerances, materials, finish etc. are documented. The new or modified drawing shall also contain the initials of the person producing the drawing and the initials of the person checking the drawing and said person shall ensure that the drawing is completed correctly.” However, the drawing file name (b)(4) pages 1, 2, and 3 are missing signature and approval dates in the “Drawn” and “Checked” blocks. In addition, the drawing file name (b)(4) is missing the Issue number.
The adequacy of your firm’s response cannot be determined at this time. Your firm has revised drawing # (b)(4) to now include initials and dates in the “Drawn” and “Checked” boxes. Drawing # (b)(4) now has the issue number inserted in the relevant box. Your firm stated that further spot checks of all documents would be performed in July, 2011, during an internal audit to ensure that all documents are completed, signed, and dated appropriately. However, your firm has not provided the evidence of implementation of all of its corrective actions or documentation for the consideration of implementing a system corrective action.
4. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures and to document the dates and results of the quality system reviews, per 21 CFR 820.20(c).
Specifically, (b)(4) titled Management Review Procedure, section 1.1.2 does not require the dates of the reviews to be documented.
We reviewed your firm’s response and conclude that it is not adequate. Your firm has added a new section 1.1.4 to (b)(4) Management Review Procedure, describing that “an attendance list shall be created for every Management Review meeting and every attendee shall sign and date this sheet to indicate that they were present at the meeting and were part to all discussions and agreed actions.” However, your firm did not provide evidence of implementation of this revised procedure. Furthermore, your firm has not provided evidence of a systemic corrective action to address this observation.
Our inspection also revealed that your firm’s Laser Doppler Blood Flow 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 to develop, maintain and implement written MDR procedures as required by 21 CFR Part 803.17.
a. Your firm’s procedure fails to establish internal systems that provide for a standardized review process or instructions for:
- Determining when an event meets the criteria for reporting events to FDA; and
- Conducting a complete investigation of each event and evaluating the cause of the event.
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 Part 803.3 for the terms: become aware; caused or contributed; malfunction; MDR reportable event, serious injury; and definitions for the terms reasonably known, found in Part 803.50(b),and reasonably suggests, found in Part 803.20(c)(1).
c. Your firm’s procedure fails to provide instructions for the timely submission of complete medical device reports including:
- The types of information to be included on the FDA Form 3500A;
- Circumstances under which an event must be submitted as a 30-day or 5-day report;
- How your firm will submit all information reasonably known to it;
- The circumstances under which your firm must submit a supplemental or follow-up report and the requirements for such reports;
- How to submit reports for events that occur outside the U.S. If an event involves a device that is the same or similar to a device with marketing approval in the U. S., then your firm must also evaluate these events for reportability and submit MDRs as required; and
- the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
d. There is no description for how your firm will address documentation and record-keeping requirements including:
- Documentation of adverse event related information maintained as MDR event files;
- 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; and
- A process to permit any authorized FDA employee to access records.
Please note that your firm’s procedure contains reporting requirements for other regulatory or competent authorities. To ensure that your firm can meet its regulatory obligations for 21 CFR Part 803, we highly recommend that it develop its MDR procedure as a separate document or as a clearly defined section of a larger document.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided the revised, renamed “Medical Device Reporting & Recall Procedure, Issue 6”; however, it does not address the deficiencies listed above.
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 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review.
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 #211373 when replying. If you have any questions about the contents of this letter, please contact: Joshua Simms at 301-796-5599 or 301-847-8138.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and