- Berwickshire Electronic Manufacturing Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
FEB 4, 2016
VIA UNITED PARCEL SERVICE
Berwickshire Electronic Manufacturing Ltd.
Unit G Industrial Estate, Station Road
During an inspection of your firm located in Duns, United Kingdom, on November 11, 2015, through November 13, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures the Helica Thermal Coagulator and the Helica LT/LTC Probes. 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. These violations include, but are not limited to, the following:
1. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, your firm has not established production and process control procedures that include:
a. Monitoring and control of process parameters, components, and device characteristics during production.
b. The approval of processes and process equipment.
c. Criteria for workmanship, expressed in documented standards or by means of identified and approved representative samples.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm's "Control of Non-Conforming Product Procedure," SOP (b)(4), does not address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. Specifically, SOP (b)(4) does not address the following requirements:
a. A determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
b. The review and disposition process.
c. Documentation of the disposition of the nonconforming product. d. Documentation of rework and reevaluation activities that include:
i. A determination of any adverse effect from rework upon the product.
ii. Testing of product after rework to ensure that the product meets its specifications in the device history records.
Additionally, according to Mr. Hastie, your firm's Secretary, your firm does not document nonconformities identified during manufacturing operations and related activities for the Helica Thermal Coagulators and Helica LT/LTC Probes.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm's "Purchasing Procedure," SOP (b)(4), does not have the requirements for:
a. Establishing and maintaining the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.
b. Evaluating and selecting potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and documenting the evaluation.
c. Defining the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
d. Establishing and maintaining records of acceptable suppliers, contractors, and consultants.
e. Establishing and maintaining purchasing data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services.
f. Documenting an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service for the purchasing data, where possible.
Additionally, your firm has not established purchasing control requirements with (b)(4). These suppliers manufacture components for the Helica Thermal Coagulators and Helica LT/LTC Probes.
4. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example: your firm does not have incoming product acceptance records for components, including parts that are manufactured and supplied per specifications. Additionally, your firm does not have documentation to assure that the solder alloy used in printed circuit board assembly conforms to specified requirements.
5. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, your firm's "Final Inspection of Probes at Berwickshire Electronic Manufacturing Procedure" does not ensure that the:
a. Finished devices are quarantined or otherwise adequately controlled until released.
b. Finished devices are not released for distribution until the activities required in the Device Master Record (DMR) are completed.
c. Associated data and documentation are reviewed.
d. Release is authorized by the signature of a designated individual(s), and the authorization is dated.
Additionally, "Delivery Notes", Form FMG41A, for the Helica LT/LTC Probes does not include the signature of the individual authorizing the release of finished devices to the contract sterilizer.
6. Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example: your firm's "Control of Monitoring and Measuring Devices Procedure," SOP (b)(4), does not include specific directions and limits for accuracy and precision; provisions for remedial action when accuracy and precision limits are not met; and documentation of these remedial actions. Additionally, your firm's equipment, (b)(4), used in the final acceptance testing of (b)(4) released Helica Thermal Coagulators, are out of calibration.
7. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm's "Corrective Action Procedure," SOP (b)(4), and "Preventive Action Procedure," SOP (b)(4), do not have the requirements for:
a. Analyzing quality data to identify the existing and potential causes of nonconforming product or other quality problems.
b. Using appropriate statistical methodology where necessary to detect recurring quality problems.
c. Verifying or validating the CAPAs to ensure that such actions are effective and do not adversely affect the finished device.
Additionally, your firm has not conducted and documented analyses of quality data.
8. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200(a). For example, your firm's "Servicing Procedure," SOP (b)(4), does not have the requirements for:
a. Analyzing service reports with appropriate statistical methodology in accordance with the requirements under your firm's CAPA system.
b. Documenting the name of the device serviced, the date of service, the individuals servicing the device, the service performed, and the test/inspection data.
c. Ensuring that the service report that represents an event which must be reported to the FDA under Medical Device Reporting Regulations (21 CFR 803) are automatically considered a complaint and process it in accordance with your firm's complaint handling requirements.
Additionally, your firm failed to adequately analyze and document two service reports (Helica TC S/N 529 and Helica TC S/N 523).
9. Failure to maintain Device Master Records (DMRs), as required by 21 CFR 820.181. For example: your firm's DMR does not include or refer to the location of device specifications for the (b)(4) used in manufacturing of the Helica LT/LTC Probe insert.
Under section 510 of the Act, 21 U.S.C. §360, manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2016.
Therefore, all of your firm's devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. §352(0), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the Helica Thermal Coagulator and the Helica LT/LTC Probes, 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. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm's response and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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 Ill devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations 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 actions (which must address systemic problems) 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 Inspections Support Branch, White Oak Building 66, Room 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #486920 when replying. If you have any questions about the contents of this letter, please contact Shumaya Ali, Acting Chief, Foreign Enforcement Branch, at email@example.com (email), +1 (240) 402-4020 (telephone), or +1 (301) 847-8138 (fax).
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 lnspectional 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.
CAPT Sean M. Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health