- Delivery Method:
- United Parcel Service
- Medical Devices
Recipient NameMr. Fritz A. Brauer
Recipient TitlePresident and CEO
- Clinicon Corp
3025 Industry St., Ste. A
Oceanside, CA 92054
- Issuing Office:
- Division of Medical Device and Radiological Health Operations West
Irvine, CA 92612-2506
CMS # 582801
UNITED PARCEL SERVICE
June 20, 2019
Mr. Fritz A. Brauer, President and CEO
3025 Industry St., Ste. A
Oceanside, CA 92054
Dear Mr. Brauer:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 3025 Industry St., Ste. A, in Oceanside, CA from April 3-4, 2019. During the inspection, an FDA investigator determined that your firm is a manufacturer (specification developer) of the SureProbe Class II sterile, single use laser accessory probes (hereafter referred to as SureProbe devices), among other devices, marketed to “deliver CO2 laser energy for the incision, excision, vaporization, ablation, coagulation or cauterization of soft tissue…”. Your website markets these probes for use in ENT, “Neuro”, and spine procedures. 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.
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 dated April 12, 2019 from your firm concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations (FDA 483) that was issued on April 4, 2019. Your response stated the Agency could anticipate another response within 90 days, and no additional information or supporting documentation of corrections was provided. Without objective evidence to verify corrections, your response is inadequate. For your reference, FDA defines “establish” under 21 CFR Part 820.3(k) as “define, document (in writing or electronically), and implement.” These violations include, but are not limited to, the following:
1. Process Validation activities and results have not been adequately documented and adequately approved per the requirements of 21 CFR Part 820.75(a).
During our inspection, your firm did not provide validation documentation for the packaging process for your SureProbe devices. In addition, you stated there has been no revalidation or reassessment of the (b)(4) sterilization process since 2015.
The initial (b)(4) validation of the SureProbe devices was conducted in May 2015 by your contract sterilizer. The validation was performed according to the requirements of (b)(4). This standard requires an (b)(4) formal assessment. In addition, the validation report states “Requalification should be performed approximately (b)(4) to detect any inadvertent process changes and to demonstrate that the original validation remains valid. Any changes to the product design, manufacturing facility location, packaging, (b)(4) or to the sterilizer equipment or process should be addressed to determine the impact of the change(s) with the original validation.” The May 2015 validation was the only validation provided for the SureProbe devices, which have been sold since 2012. In addition, please provide in your written response the justification for the two-year expiration dating applied to sterile product packaging.
Packaging is critical to ensure maintaining a barrier to protect sterile product. Our investigator requested documentation to demonstrate process validation was completed for package sealing of your sterile products. The documentation provided consisted of the Sealing Procedure, revision A, dated 6/13/2011, which notes specified time and temperatures for sealing, and requires a visual inspection for “leaks” under a (b)(4). A presentation was also provided with further guidance on sealing including photos, criteria such as “(b)(4)” and “(b)(4)”, etc. This document references (b)(4) and states a process validation program is required “to validate the efficacy and reproducibility of all sterilization and packaging process, and this validation must be documented.” You told our investigator that no package integrity testing has been performed and you could not provide evidence to show how the packaging procedure was developed per a protocol with pre-approved acceptance criteria, test data, or any final report to validate the sealing process can maintain sterility barrier. In addition, the Sealing Procedure you provided states on the (b)(4) and 240mm SureProbe devices, a piece of (b)(4) will be added to the WaveGuide Fiber end to prevent breakage when removing the SureProbe devices from packaging for use. Any written response should include if this additional tubing used during packaging was considered in your 2015 sterilization validation.
Regarding other process validations, please notify this office in writing whether or not the (b)(4) coating process used for solution coating of the capillary tubing has been validated.
The documentation maintained by your firm does not demonstrate a validation has been maintained for the (b)(4) process, or performed for your packaging process. Please review the requirements of 21 CFR Part 820.75 and provide information as to how you are ensuring sterilization and maintaining the sterile barrier for your products currently being distributed and in future. We also request that you review your procedures to ensure they meet the requirements, and implement those procedures to include retention of applicable records. Please provide our office a timeframe for when this can be completed, a copy of the procedure if it is updated, and records such as the final report showing results of each validation.
2. Equipment calibrations, inspections, checks, and maintenance activities have not been documented per the requirements of 21 CFR Part 820.72(a).
In addition to our concerns elucidated in item 1 regarding the lack of packaging validation, you also told our investigator you are not calibrating or maintaining the pneumatic heat sealer used to create the sterile barrier on your laser probes. This piece of equipment includes a digital temperature controller, a digital timer, air pressure gauge, (b)(4), etc., and the instructions state if the (b)(4), it could cause inaccurate temperature control.
You provided an Inspection Measuring and Test Equipment procedure, Revision C, dated 6/2/2010, which requires “the equipment manufacturer’s or industry standard recommended procedures for the particular type of equipment…” be followed unless special requirements are applicable. The sealer operating instructions recommends (b)(4) calibration. You stated you had a former employee who took care of many quality functions such as these who left the firm approximately one year ago and since that time documents have been difficult to locate. As the manufacturer, you are responsible for ensuring the quality of the medical devices you distribute.
Please review the requirements of 21 CFR Part 820.72 to ensure your procedure is sufficient, and include in your written response how you will correct this sealer maintenance issue.
3. The evaluation of potential suppliers and contractors was not documented, per the requirements of 21 CFR Part 820.50(a).
During our inspection, you provided the Supplier Evaluation and Qualification procedure, Revision C, dated 6/2/2010, which requires suppliers to be qualified and have their evaluations documented and on file before approval. For example, “key” materials that are essential for safe and reliable function of the product require evaluation via multiple options which must then be reviewed by Quality Assurance, Purchasing, etc., to determine if the supplier meets requirements. Once suppliers are selected, this procedure also requires evaluation with frequency dependent upon the “level” chosen for the supplier and that associated records be maintained. You could not provide any evaluations or approvals for your suppliers of raw materials for the SureProbe devices, distributed since 2012. This procedure also requires documented evaluation for service providers “whose activities may have an effect on product quality” and no such documentation could be provided for your (b)(4) during our inspection.
In addition, this procedure is written with different departments being delineated specific responsibilities. It may be of benefit to review this procedure and update it according to the current personnel you have on hand.
We ask that you review 21 CFR Part 820.50, update procedures as necessary to meet the requirements, and implement those procedures to include retention of applicable records. Please be aware in your review of this section that the regulation also applies to consultants. Please notify this office in writing of the timeframe when this is completed, provide a copy of the procedure (if updated) once it is in place, and an example of records showing the new procedure has adequately corrected this issue.
4. A device history record has not been maintained per the requirements of 21 CFR Part 820.184.
During our inspection, you could not provide an established procedure that governs how Device History Records (DHRs) are maintained. You explained the manufacturing process to our investigator for the SureProbe devices and provided a testing procedure, but could not provide records demonstrating these activities have been performed for your distributed probes. In addition, no sterilization records for recent lots distributed could be provided.
We request that you review the requirements of 21 CFR Part 820.184 and establish a procedure to meet these requirements. Please notify our office when this procedure has been implemented and provide a copy as well as an example of a completed DHR.
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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
If you have questions regarding any issues in this letter, please contact Compliance Officer, Lauren Priest at 303-236-9663 or at Lauren.Priest@fda.hhs.gov. Please send your reply electronically to .
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.
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health