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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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KeyMed (Medical and Industrial Equipment) Ltd.

  

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
 

JUN 20 2008
 

WARNING LETTER

VIA FEDERAL EXPRESS {AND FACSIMILE}
 

Mr. Steven J. Brown
Director, R&D and Manufacturing
KeyMed, Ltd.
KeyMed House, Stock Road
Southend-On-Sea, Essex SS2 5QH
United Kingdom, England

Dear Mr. Brown:

During an inspection of your firm located in Southend-On-Sea, Essex on October 22-25, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures mobile workstations for use with endoscopes and suction pumps. 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Mr. Steven J. Brown, Director, Research and Development and Manufacturing, dated November 7 and 8, 2007, and Dr. Gurge Phull, General Manager, Quality Assurance and Regulatory Affairs dated November 28, 2007, and January 15, 2008, concerning our investigator's observations noted on the Form FDA 483, List of inspectional Observations that was issued to you. We address these responses 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 to control the design of the suction pumps in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example, in Section 7.3 of the KeyMed Quality Manual, definitions of Design Inputs, Design Outputs, Design Verification, Design Validation and Design Changes are listed; however, specific procedures related to Design Verification (Section 7.3.5), Design Validation (Section 7.3.6), and Design Changes (Section 7.3.7) were not available. The lack of these procedures indicates that your firm lacks procedures to control the design of suction pumps.

Your responses dated November 7, 8, and 25, 2007, and January 15, 2008, are not adequate because you did not address the issue of not having Design Control procedures.

2. Failure to establish and maintain a procedure for implementing corrective and preventive action, which includes requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example, Section 8.3 and Section 8.5.2 of the KeyMed Quality Manual describe non-conforming products and complaints, respectively; however, in the descriptions there are no procedures for analyzing non-conforming products and complaints or how these issues can rise to the level of a CAPA.

Your responses dated November 7, 8, and 25, 2007, and January 15, 2008, are not adequate because your new Corrective and Preventive Action procedure does not include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. In addition, it does not include requirements for verifying or validating the corrective and preventive action to ensure that the action is effective and does not adversely affect the finished device.

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, with respect to the suction pumps, management can make changes to design drawings, products, or processes, without sharing this information with other personnel through a process called "concessions." Such a process lacks documentation, for example, Engineering Change Request (b)(4) was implemented for the (b)(4) filter housing under Change Order (CO) (b)(4) on February 7, 2006, by the Engineering Manager of Mechanical Design. Three weeks later, on February 28, 2006, Engineering Change Request (b)(4) was created by the subordinate of the Engineering Manager to complete the same modification under CO (b)(4). Because "concessions" allow management to make changes without sharing the changes with other personnel, the same change was made twice.

Your responses dated November 7, 8, and 25, 2007, and January 15, 2008, are not adequate because although you submitted your Change Control procedure, the procedure did not address verification/validation of changes prior to implementation. In addition, you failed to discuss the necessary training for the new procedures and how the Concessions procedure and the Design Changes procedure will ensure this practice does not occur in the future.

4. Failure to establish and maintain adequate complaint handling procedures to ensure that any complaint involving the possible failure of a device, labeling or packaging to meet specifications shall be reviewed, evaluated and investigated, as required by 21 CFR 820.198(c). For example, the Endosonic bath was the subject of various complaints referencing E1, E3, or E4 error messages. These error messages were related to software problems. Investigations into each of these complaints were incomplete and did not focus on determining the cause or preventing reoccurrence of the errors. Instead, temporary solutions and workarounds were used in order to get the product into the market. An example of a workaround includes engineering change request, (b)(4), which led to a software update through Software Change Request, SCR (b)(4), to temporarily correct the issue.

Your responses dated November 7, 8, and 25, 2007, and January 15, 2008, appear to be adequate in that your new Corrective and Preventive Action procedure includes requirements for identifying and analyzing nonconformities and investigating to determine root cause.

5. Failure to adequately 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 CFR 820.22. For example, in Section 8.2.2 of the KeyMed Quality Manual, internal audits are to take place at least (b)(4); however, issues relating to design changes and corrective and preventive actions were not subject to internal audits on an (b)(4).

Your responses dated November 7, 8, and 25, 2007, and January 15, 2008, are not adequate because the responses did not specifically address audits in the areas of design changes and corrective and preventive actions.

6. Failure to establish and maintain procedures to control all documents that are required by 21 CFR Part 820; in particular, each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented, as required by 21 CFR 820.40(a). For example, The KeyMed Quality Control Manual has not been reviewed (and therefore not approved) to determine if the procedures documented match the current system in place.

Your responses dated November 7, 8, and 25, 2007, and January 15, 2008, are not adequate in that no analysis or retrospective review, corrections or corrective actions have been performed.

Given the serious nature of the violations of the Act, the mobile workstations for use with endoscopes and suction pumps 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. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. 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 violation(s), or similar violation(s), 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:

Mr. Paul F. Tilton, Chief
Obstetrics, Gynecology, Gastroenterology and Urology Devices Branch
Division of Enforcement A, Office of Compliance, CDRH
2098 Gaither Road, HFZ-332
Rockville, MD 20850

If you have any questions about the content of this letter please contact Ms. Leslie E. Caster at 240-276-0115 or by facsimile at 301-276-0114.

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, 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 yours,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and Radiological Health