Inspections, Compliance, Enforcement, and Criminal Investigations
Cameron-Miller, Inc. 28-Sep-07
Department of Health and Human Services
Public Health Service
September 28, 2007
RETURN RECEIPT REQUESTED
Mr. John W. Martin, President
5410 W. Roosevelt Road, # 241
Chicago, Illinois 60644-1478
Dear Mr. Martin:
During an inspection of your firm located in Chicago, Illinois, on April 24, 2007 through May 10, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrosurgical, cutting & coagulation devices & accessories. 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 (C.F.R.), Part 820. We received your responses, dated May 16, 2007, and June 13, 2007, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations, which 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. Your firm's management with executive responsibility failed to establish its policy and objectives for, and commitment to, quality. Management shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization, as required by 21 C.F.R. § 820.20. For example, you failed to establish a quality policy, to comply with 21 C.F.R. § 820.20(a). [Observation 2]
Your response, dated June 13, 2007, states that you intend to produce a quality policy in accordance with 21 C.F.R. § 820.20(a), and will ensure that the policy is understood by all company personnel through the use of appropriate training sessions. We will evaluate the adequacy of this response during the next FDA inspection of your facility.
2. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. For example, although your firm's internal quality audit procedure includes a review of your complaint files to determine if any complaints represent an MDR reportable event, your internal audits failed to uncover complaints reported in December of 2004, and April of 2007, that represented MDR-reportable events, but were never filed with the FDA. [Observation 3]
Your response, dated June 13, 2007, states that additional training sessions will be held to ensure that all complaints (including MDR reportable events) are handled in a timely fashion. Your response also states that you intend to design new forms, to make compliance easier to achieve. We will evaluate the adequacy of this response during the next FDA inspection of your facility.
3. Failure to adequately document the disposition of nonconforming product, including the justification for use of nonconforming product, as required by 21 C.F.R. § 820.90(b)(1). Specifically, your firm received a shipment containing 530 ball tips, part number 26-1105-04, from [redacted] Your firm's inspection report, dated January 12, 2007, lists these parts as rejected, with the reason for rejection listed as 1/32" radius missing. A memorandum from [redacted] dated May 9, 2007, states that your firm "decided to keep parts and rework them ourselves during our assembly process," No justification for use of the non-conforming product was provided. [Observation 4]
Your response, dated June 13, 2007, states that you intend to modify the "Acceptance Activities" section of your Quality Assurance Manual to provide appropriate procedures and forms for use of non-conforming items. We will evaluate the adequacy of this response during the next FDA inspection of your facility.
4. Failure to establish procedures to identify training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, and failure to document training, as required by 21 C.F.R. §$20.25(b). Specifically, your firm has not established a formal training program, and does not document any personnel training. Therefore, there is no documentation to show that, as part of their training, personnel are made aware of device defects which may occur from the improper performance of #heir specific jobs, as required by 21 C.F.R. § 820.25(b)(1 ). [Observation 5]
Your response, dated June 13, 2007, confirms that your firm has not maintained documentation for training. Your response states that, on May 23, 2007, a training session form was introduced, and will be used to document all future training. Your response to this observation is inadequate because it does not address your firm's lack of established procedures to identify training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
5. Failure to review all associated data and documentation prior to distributing finished devices, as required by 21 C.F.R. § 820.80(d)(2). For example, the device history record for Electrosurgical Unit Model 26-0339, Serial Number 341, indicates that the device was distributed prior to final review and release. Specifically, the Release Authorization section of the "Final Inspection and Calibration Record" was not completed prior to the distribution of the device. [Observation 6]
Your response, dated June 13, 2007, states that your "paperwork procedures have been unduly complicated and as a result complete and proper documentation have been lacking/mis-filed." Your response further states that your files are currently being reviewed to ensure that all documents are correctly filed in a timely fashion. In addition, your firm intends to conduct and document a monthly file review. We will evaluate the adequacy of this response during the next FDA inspection of your facility.
6. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all of the requirements of 21 C.F.R. § 820.198(a) through (e) are met. For example, the Customer Complaint Analysis (Form 93-002) records for complaints received by your firm on December 17, 2004, March 13, 2007, and April 4, 2007 are incomplete, in that the following sections of the forms for these complaints are only partially completed, or not completed at all: Customer Data; Technical; Customer Service; Manufacturing; and, Shipping. In addition, your firm failed to include in the complaint file adequate records of complaint investigations. [Observation 7]
Your response, dated June 13, 2007, states that your "complaint system and forms need to be updated." Your response further states that you intend to begin quarterly trend analysis on complaints. Your response to this observation is inadequate because it does not describe the specific steps that your firm will take to ensure compliance with the requirements of 21 C.F.R. § 820.198(a) through (e).
7. Failure to meet servicing requirements as specified in 21 C.F.R. § 820.200. For example, repairs of electrosurgical units are not being adequately documented as required by 21 C.F.R. § 820.200(d). Electrosurgical unit repair records reviewed during our inspection found the records to be incomplete, and lacked approval signatures and dates. In addition, several units which failed to meet specifications were released and subsequently distributed. [Observation 8]
Your response, dated June 13, 2007, attributes these deficiencies to the excess complexity of your paperwork procedures, and states that these items will be addressed. Your response to this observation is inadequate because it does not describe the specific steps that your firm will take to ensure compliance with the requirements of 21 C.F.R. § 820.200.
8. Failure to document corrective and preventive action (CAPA) activities, including investigations of causes of nonconformities, as required by 21 C.F.R. § 820.100(b). Specifically, your firm failed to conduct and/or document the dates and results of investigations to determine the root cause of product complaints. [Observation 9]
Your response, dated June 13, 2007, states that your "complaint system and forms need to be updated." Your response further states that you intend to begin quarterly trend analysis on complaints similar to the reviews currently being done under your corrective and preventive action procedures. Your response to this observation is inadequate because it does not describe the specific steps that your firm will take to ensure compliance with the requirements of 21 C.F.R. § 820.100.
9. Failure to establish and maintain adequate procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 C.F.R. § 820.90(b)(2). Specifically, your firm has not established and maintained any rework procedures. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, are not documented.
Your response, dated June 13, 2007, states that procedures and documentation for non-conforming items will be produced. Your response further states that the "Acceptance Activities" section of your Quality Assurance Manual will be modified to provide appropriate procedures and forms for such future events. We will evaluate the adequacy of this response during the next FDA inspection of your facility.
10. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. For example, your firm provided our investigator with a list of component suppliers. This document is not adequate, as it does not establish and help maintain specified requirements, including quality requirements, that suppliers must meet. 21 C.F.R. § 820.50(a). [Observation 11]
Your response, dated June 13, 2007, states that you "will review these comments in light of 21 C.F.R. § 820.50." Your response to this observation is inadequate because it does not describe the specific steps that your firm will take to ensure compliance with the requirements of21 C.F.R. § 820.50.
Our inspection also revealed that your firm failed to meet the medical device reporting requirements established under 2l C.F.R. Part 803. [Observation 1] Significant deviations include, but are not limited to, the following:
1. Failure to conduct an investigation of each event and evaluate the cause of the event, as required by 803.50(b)(3). [Observations 1, 3, 5, 6] For example:
a. A complaint, dated December 17, 2004, had no complaint information other than "warranty repair." The electrosurgical units (ES) repair record had a complaint that read "Per [redacted] while using unit it shocks patient and also Dr." There was no information in this complaint to determine if there was any injury to the doctor or patient when they were shocked.
b. Another complaint, dated April 4, 2007, had no complaint information other than "see letter." A letter from a physician to the firm included in the complaint contained the information " . . . and third some of our patients are experiencing burns to their lower extremities despite the fact that we are using the grounding pad in the proper fashion." There was no information in the complaint to determine the severity of the patients' burns and whether treatment was required for the burns. Neither complaint showed any investigation of the reported events.
Your response dated May 16, 2007, states that these two events "are both being investigated and MDR reports will be filed as soon as these investigations are completed." Your response dated June 13, 2007, states that "[a] MDR report was filed on May 17, 2007 for the 12/17/ complaint" and that "[a] MDR report will be filed on the 4/4/07 complaint as soon as we have completed our investigation (we are still awaiting data from the doctor's office)." We received these two MDR reports, the first on May 17, 2007, and the second on June 14, 2007. During the next FDA inspection of your facility, we will evaluate the adequacy of your investigations of these and other events, and of your related submissions to FDA, to ensure compliance with 21 C.F.R. §§ 803.50(b) and 803.52. (As indicated below, your MDR investigations and related submissions to FDA must be documented in your files. 21 C.F.R. §§ 803.17(b)(1)-(2) & 803.18.)
2. Failure to have written MDR procedure in place which would provide for timely and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirement or a standardized review process or procedure for determining when an event meets the criteria for reporting under 21 C.F.R. Part 803.21 C.F.R. § 803.17(a). Further, your firm does not have written documentation and recordkeeping requirements for information that was evaluated to determine if an event was reportable, as required by 21 C.F.R. § 803,17(b)(1), and does not have systems that ensure access to information that facilitates timely follow-up and inspection by FDA, as required by 21 C.F.R. § 803.17(b)(4). For example, your firm's document that references complaint handling also contains a reference to MDR. This document is insufficient because it lacks specified requirements in Part 803 to help identify, communicate, and evaluate events that may-be reportable. Among other deficiencies, it lacks information on submitting individual adverse event reports, baseline reports, and supplemental reports. 21 C.F.R. §§ 803.50, 803.52, 803.55, 80356. Without this and other important information, your written MDR procedure does not meet the requirements in 21 C.F.R. § 803.17(a) for proper identification, communication, and evaluation of events that may be reportable. [Observation 1]
Your response, dated June 13, 2007, states that you have already held one MDR training session "to emphasize the need for vigilance concerning complaints/events which might involve MDR reportable events." Your response further states that you plan to "make new forms which more clearly spell out the need for MDR event complaints to be separate from 'normal' complaints," and that you will hold additional MDR training sessions when these new forms are available. We will evaluate the adequacy of your response during the next FDA inspection of your facility, to ensure that your new MDR procedure provides for timely and effective identification, communication, and evaluation of events that may be reportable, and further complies with the relevant documentation and recordkeeping requirements. 21 C.F.R. § 803.17.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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 (QS) 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.
We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 C.F.R. Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
• Initial certifications by consultant and establishment - received in this office before or by April 1, 2008.
• Subsequent certifications -received in this office before or by April 1, 2009.
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 violations or similar violations, 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.
Your response should be sent to: Patrick J. Brown, Compliance Officer, 550 West Jackson Blvd., 15th Floor, Chicago, IL 60661. If you have any questions about the content of this letter please contact Mr. Brown at 312-596-4214.
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 (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.
Scott J. MacIntire