Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Denver District Office|
Building 20 - Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
February 20, 2013
VIA UPS Overnight Mail
Mr. Brian Qualls
CoRE Labs, LLC
3720 S. Lipan Street
Englewood, CO 80110-3479
Ref: # DEN-13-07-WL
Dear Mr. Qualls:
During an inspection of your firm located in Englewood, CO conducted from July 16 through 25, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Flora Wall Bucky Stands and Atlas Radiographic Tables. 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 any function of the body.
Section 538(a) of Subchapter C, Electronic Product Radiation Control, of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 360oo(a)), prohibits any manufacturer from certifying or introducing into commerce diagnostic x-ray products which do not comply with the standard. Failure to establish and maintain required records or to submit required reports is also a prohibited act under Section 538(a). Our inspection revealed that your firm was not in compliance with the requirements, in that significant violations include, but are not limited to, the following:
1. Failure to maintain records of tests for electronic product radiation safety as required by 21 CFR 1002.30(a)(2). Specifically, your firm manufacturers radiographic tables and vertical cassette holders which have a maximum allowed aluminum equivalent material between the patient and image receptor prescribed by 21 CFR 1020.30(n). IROM Imaging, Inc. was acquired by and re-named CoRE Labs in 2004; IROM Imaging’s Abbreviated Reports (called “Initial Product Reports” by IROM Imaging) dated 06/28/2000 (Atlas Table) and 01/22/2001 (Flora Bucky Stand) contain Aluminum Equivalence testing procedures which call for lot testing and provide instructions for documenting results on a Q.C. data sheet. However, no such documentation could be provided for the testing of the aluminum equivalence of the material between the patient and the image receptors. All (b)(4) of the reviewed Device History Records revealed no data regarding the testing for Aluminum Equivalence.
2. Failure to furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under 21 CFR Subchapter J, as required by 21 CFR 1010.2(a). Specifically, a review of the product labeling for the Atlas Elevating Table and Flora Wall Bucky Stand reveals that no certification label is provided with the finished device.
In addition, the testing procedures for assuring conformance with applicable performance standards (on which the above certification must be based) are found in IROM Imaging’s (the former name of CoRE Labs) Initial Product Reports, dated 06/28/2000 (Atlas Table) and 01/22/2001 (Flora Bucky Stand). However, these procedures are outdated concerning the changes to 21 CFR Subchapter J effective June 10, 2006. Specifically, your firm’s Aluminum Equivalence testing procedures, found in the Initial Product Reports, call for an x-ray source with an output of 100 kV and an HVL of 2.7 mm/AL. However, systems manufactured after June 10, 2006 are required to use an x-ray source with an output of 100 kV and an HVL of 3.6 mm/AL for Aluminum Equivalence testing (21 CFR 1020.30(n)).
3. Failure to submit an abbreviated report prior to introduction of a product, as required by 21 CFR 1002.12, for products requiring such a report as specified in 21 CFR 1002.1, Table 1. Specifically, your firm manufacturers the Atlas Elevating Table and the Flora Wall Bucky Stand both of which, according to Table 1 of 21 CFR 1002.1, require the submission of an abbreviated report. Our records indicate that the required Abbreviated Reports were submitted by IROM Imaging Inc. which was later acquired by CoRE Labs. However, an abbreviated report has not been filed for either device on behalf of CoRE Labs upon acquiring the Flora Wall Bucky Stand and Atlas Elevating Table product lines.
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act 21 (USC § 352 (t)(2)), in that your firm failed or refused to furnish material or information regarding the devices that is required by or under section 519 of the Act(21 USC § 360i) and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “CoRE Labs MDR Procedure,” the following issues were noted:
- There is no evidence that your firm’s MDR procedure is implemented. For example, there is no effective date for the procedure.
- Your firm’s MDR procedure 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:
A. 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 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found in 21 CFR 803.50(b) and 803.20(c)(1), respectively.
- Your firm’s MDR procedure 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:
A. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
B. The procedure, as written, does not specify who makes the decision for reporting events to FDA.
- Your firm’s MDR procedure 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. How your firm will submit all information reasonably known to it for each event.
C. The circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports.
D. The procedure does not include the address for submission of MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
- Your firm’s MDR procedure does not address documentation and record-keeping requirements, including:
A. Information that was evaluated to determine if an event was reportable.
B. 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.
In addition, your firm’s procedure includes references to baseline reports. Baseline reports are no longer required and all references to a Baseline Report should be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 violations 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, as well as 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
In addition, FDA has noted nonconformities with regard to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
- Failure to establish and maintain adequate procedures for acceptance activities including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). Specifically, the in-process and finished device acceptance activities are tracked on a “Pre-Shipment Check List”. However, no procedures exist to ensure these acceptance activities are consistently and uniformly followed.
- Failure to adequately develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). Specifically, your firm’s Process Control Procedure requires all processes to be documented, including the Part # Drawing, Quantity, Materials Used, Operations Performed, Description, Start Date, Finish Date and Operator. The procedure also requires measurement of parts during non-automated and automated operations. However, your firm currently does not maintain any records for the milling and lathing operations, including the inspection of parts.
- Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, neither the Procedure Manual, Section 14.0 (Control of Nonconforming Product), nor the supplementary procedure (Dye Marking—Layout Fluid—Quarantined Parts) requires the documentation, evaluation or investigation, as needed, of non-conforming products.
- Failure to maintain adequate device master records (DMRs) as required by 21 CFR 820.181, and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40. Specifically, the DMR for the Atlas and Aries Radiographic Tables does not include or refer to the location of:
A. Production process specifications, including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
B. Quality Assurance procedures and specifications (including acceptance criteria and the equipment to be used); and
C. Packaging and labeling specifications (including methods and processes used).
- Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and testing, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm uses (b)(4) machines for automated milling and lathing processes. These processes are used to drill, tap, lathe and mill a variety of materials used in the production of CoRE labs, LLC medical devices, including stainless steel, steels, acetal plastics, and aluminum. These processes have not been validated and, according to the Managing Member, are not fully verified.
- Failure to establish and maintain adequate 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, no records were available for review to demonstrate that the following suppliers were evaluated prior to the purchase and receipt of components used in the manufacture of the Atlas Elevating Radiographic Table.
Additionally, Section 9 of the Procedures Manual, Purchasing, does not require, where possible, an agreement in which the suppliers agree to notify the manufacturer of changes in the product.
- Failure to establish and maintain adequate 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, Section 8 of the Procedures Manual, Design Control Procedure, specifies that:
“Changes in specification that lead to design revisions of released products are documented on the Design & Development Worksheet where applicable…”
However, a review of your firm’s Part Drawings which were revised due to design changes, revealed that your firm did not validate or where appropriate verify (or document the change on a Design & Development Worksheet) any of the (b)(4) design changes as follows:
- Failure to establish and maintain adequate procedures to ensure that Device History Records (DHRs) for each unit are maintained to demonstrate that the device is manufactured in accordance with the DMR, as required by 21 CFR 820.184. Specifically, all (b)(4) of the inspected DHRs failed to include one or more of the following:
A. primary identification label and labeling used for each production unit,
B. date and signature of the individual(s) conducting final release of the devices,
C. device identification (Serial Number),
D. dates of manufacture and testing were performed, and
E. final reviewer signature.
- Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints to ensure all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1). For example: your firm’s Complaint Handling Procedure states, “The internal review of a complaint will involve no less than (b)(4) of the CoRE labs staff.” However, the procedure contains handwritten notations regarding the aforementioned requirement, consisting of an arrow drawn to the word (b)(4) leading from the handwritten words (b)(4). This edit may result in non-uniform processing of complaints, and there is no documentation this edit was approved.
In addition, a complaint was received on 4-16-2012 for a (b)(4). The possible cause was determined to be due to a (b)(4). However, no additional investigation took place to determine if the supplier was the cause of the non-conformance and to ensure that appropriate corrective actions were implemented as needed.
- Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained, as required by 21 CFR 820.72(a). For example:
A. The document titled “Master List of Equipment that Requires Calibration” lists (b)(4). However, no documentation could be provided to show that the calipers and micrometer had been calibrated in 2009, 2010, or 2011.
B. Section 11 of the Procedures Manual, Control of Monitoring and Measuring Devices, calls for physical gauges and mechanical measuring equipment to be calibrated on a (b)(4) schedule. However, your firm has not established a system to determine how many days each gauge and piece of mechanical measuring equipment have been used.
- Failure to establish and maintain adequate calibration procedures for inspection, measuring, and test equipment including traceability of calibration standards to national or international standards as required by 21 CFR 820.72(b). For example, Section 11 of the Procedures Manual, Control of Monitoring and Measuring Devices, calls for physical gauges and mechanical measuring equipment to either be calibrated in-house or sent out for certified outside calibration. However, no procedures exist for in-house calibration which should also include traceability to national or international standards
- Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1). Specifically, your firm has not established maintenance schedules for the following (b)(4) machines used in the manufacture of all CoRE labs Radiographic Systems:
- Failure to establish and maintain adequate 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. Specifically, Section 12 of the Procedures Manual, Internal Quality Audits, calls for the Management Representative to schedule quality audits and to report results during management review. According to Section 5 of the Procedures Manual, management reviews are scheduled, either (b)(4). However, no documentation could be provided to verify that any Quality Auditshad been performed from 2009-2012.
- Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). Specifically, Section 5 of the Procedures Manual, Management Review Procedure, calls for management review meetings to be held at a minimum of (b)(4). In the copy of the Procedures Manual, however, the word (b)(4) was written above in pen. Documentation could not be provided of the dates or results of Management Reviews from 2009, 2010, 2011, or 2012.
- Failure to establish adequate procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities and document the training, as required by 21 CFR 820.25(b). Specifically, Section 16 of the Procedures Manual, Training, states that individual training records are to be maintained and updated as part of the employee’s training file. However, your firm has not established training requirements or training files for any of the current employees of your firm. (The Procedures Manual, Table of Contents lists training as Section 16; however, the manual itself includes two sections labeled as 15, one for Corrective and Preventive Action and one for Training. In sequential order, Training, is section 16.)
- Failure to approve quality system documents by a designated individual for adequacy prior to issuance, including the date and signature of the individual(s) approving the documents as required by 21 CFR 820.40(a). Specifically, all sixteen sections of the Procedures Manual have not been signed and dated for approval.
- Failure to review and approve quality system document changes and maintain records of document changes including a description of the change, identification of the affected documents, signature of the approving individual(s), approval date, and when the change becomes effective, as required by 21 CFR 820.40(b). Specifically, (b)(4) of the 16 sections of the Procedures Manual contain handwritten changes written in pen. None of the changes include a signature of the approving individual(s), approval date, and when the change became effective.
We have received your October 26, 2012 email correspondence which was submitted in response to the FDA-483, List of Inspectional Observations. Your response will be made part of our official files. We cannot consider your October 26, 2012 response to be satisfactory as there are several issues noted above that were not addressed in your initial correspondence. We will verify all corrective actions during a future inspection.
Your response should be sent to: U.S. Food and Drug Administration, Denver District Office, Building 20 – Denver Federal Center, P.O. Box 25087, Denver, CO 80225-0087, Attn: Sarah A. Della Fave, Compliance Officer. If you have any questions about the contents of this letter, please contact: Ms. Della Fave at 303.236.3006.
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.
LaTonya M. Mitchell