- Aros Surgical Instruments Corporation
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
September 25, 2015
WL # 36-15
Mr. Frederick L. Phelps
Aros Surgical Instruments Corporation
Newport Beach, California 92660-3920
Dear Mr. Phelps:
During an inspection of your firm located in Newport Beach, California, on February 2 through February 6, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical sutures and micro anastomosis clamps. 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 from you, dated February 20, 2015, to the observations noted on Form FDA-483, List of Inspectional Observations, which was issued to your firm. 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 device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1).
For example, your firm did not maintain design control documentation for the design of your surgical sutures. We have reviewed your response and conclude it is inadequate. We cannot verify the implementation of your procedure, SOP 73-01, Design Control, effective date 2/6/15. In this response, you submitted a retrospective design history file for your surgical sutures. The design documentation for your surgical sutures was inadequate, and is addressed in our discussion of Item (5) in this letter.
You also have not addressed the fundamental deficiency or lack of proper design control processes and procedures which should have been in place before these devices were placed into interstate commerce.
2) 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, your firm implemented the following design changes to your medical devices without following established procedures:
- Changing the sterilization method: (b)(4) for your micro anastomosis clamp devices and from (b)(4) to E-Beam for your surgical suture devices
- Material change for the hinge pin and spring from (b)(4) for your micro anastomosis clamp devices
- Addition of curved versions of your micro anastomosis clamp devices, Model Numbers HK-1 and HK-2
- Addition of micro anastomosis clamps with different closing forces (15 g and 120 g)
When requested by our investigator, you were unable to provide any documentation for the changes in sterilization methods, and incomplete documentation was provided for the other design changes referenced above.
We have reviewed your response and have concluded it is inadequate. You provided SOP 73-01, Design Control, but this procedure does not require validation or where appropriate verification of design changes. With respect to your surgical sutures and micro anastomosis clamp devices, you have not identified the change in sterilization method for either device (b)(4), you have not maintained documentation of these changes, and have not reviewed and approved these changes. The validations for the changes in sterilization method were provided in (b)(4); therefore we cannot comment on their adequacy. Additionally, the “design tracking” documents for your micro anastomosis clamps reference a “Visual Review of (b)(4) prior to Purchase” as the verification method for the material change for the hinge pin and spring, the addition of curved versions, and the addition of micro anastomosis clamps with forces ranging from 15 g to 120 g. This is inadequate, and does not ensure these changes are validated to ensure the devices conform to defined user needs and intended uses.
3) Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm does not have purchasing control procedures to ensure your suppliers, contractors and consultants meet specified quality requirements. We have reviewed your response and have concluded it is inadequate. You provided SOPs 74-03, Receiving, 74-02, Purchasing, and 74-01, Supplier Evaluation. We cannot verify the implementation of these procedures.
4) Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, and failure to establish agreements with suppliers and contractors to notify you of changes in their products or services, as required by 21 CFR 820.50(b). For example, you do not maintain records that clearly describe or reference specified requirements, including quality requirements that the contract manufacturer of your surgical sutures and micro anastomosis clamps must meet. Additionally, you do not have an agreement with this contract manufacturer to notify your firm of changes in the products manufactured under your brand name. Our inspection revealed a change in sterilization method for your micro anastomosis clamps from (b)(4), and a change in sterilization method for your surgical sutures from (b)(4) to Electron Beam. We have reviewed your response and have concluded it is inadequate. You provided SOPs 74-02, Purchasing, but have not demonstrated its implementation
5) Failure to establish a design history file, as required by 21 CFR 820.30(j). For example, you did not establish and maintain a design history file for your surgical sutures, and you did not maintain a design history file documenting design changes for your micro anastomosis clamps. We have reviewed your response and have concluded it is inadequate. You provided SOP 73-01, Design Control, and “Design Input/Output Forms” for your surgical sutures and micro anastomosis clamps. The “Design Input/Output Form” for your micro anastomosis clamps does not reference an approval regarding the change in sterilization method from ((b)(4). Additionally, this form specifies “Radiation per ISO 11137” at (b)(4) for the micro anastomosis clamps, without specifying if this is Gamma, E-Beam or X-Ray. The “Design Input/Output Form” for your surgical sutures references (b)(4); however our inspection indicated you now use E-Beam radiation for these devices. Additionally, your “Design Input/Output Form” references “sterilization validation” as the verification method for sterility for each device, and as previously referenced in this letter, you have not demonstrated the sterilization method for either device has been validated.
6) Failure to adequately maintain records of changes to documents, as required by 21 CFR 820.40(b). For example, your firm made the following changes on "Document Change Forms":
- “In-house re-labeling activities have been removed from operations. Therefore the forms must change to show these changes in receiving inspection.” Approval date 1/18/10
- “Update box label specification to new labeling.” Approval date 1/18/10
- “Change of Manufacturer's Material Number form for Suture due to additional product numbers.” Approval date 5/25/10
- “Update Quality System after Internal Audit by (b)(4) and to update to new regulatory requirements.) Approval date 7/22/10
Your change records did not include a description of the change and identification of the affected documents. We have reviewed your response and have concluded it is inadequate. You provided SOP 42-01, Control of Documents, but have not demonstrated its implementation.
7) Failure to maintain a device master record, as required by 21 CFR 820.181. For example, your firm did not maintain a device master record prepared and approved in accordance with 21 CFR 820.40. Your device master records were incomplete, in that they did not reference complete device specifications, production process specifications, quality assurance procedures and specifications, and packaging and labeling specifications.
We have reviewed your response and have concluded it is inadequate. You provided SOP 42-02, Device Master Record. This procedure has not been fully implemented. The device master records included in your response do include complete device specifications; do not reference production process specifications, quality assurance procedures and specifications, as well as packaging and labeling specifications.
8) Failure to ensure that individuals conducting quality audits do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, your firm provided documentation to the FDA investigator during the course of the inspection referencing that (b)(4) conducted audits of the AroSurgical Instruments quality system on (b)(4). We have reviewed your response and have concluded it is inadequate. You provided SOP 82-02, Internal Quality Audits. This procedure has not been fully implemented. Additionally, your response provides information that is inconsistent with the information provided to our investigator. This response includes Audit Cover Sheets referencing (b)(4) performed these audits on these same dates.
FDA has also reviewed information collected information during our recent inspection and determined that the micro anastomosis clamp is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Micro anastomosis clamp is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with a change or modification that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source or manufacturing process without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(i). Specifically, you have modified the micro anastomosis clamp, cleared under K961100, by the following:
● Changed the sterilization method from (b)(4);
● Changed the micro anastomosis clamp’s component materials from (b)(4);
● Changed the micro anastomosis clamp’s closing force; and
● Changed the design of the micro anastomosis clamp from straight to curved.
The change in sterilization method and change in materials may have affected the biocompatibility of the device. The material change from (b)(4), the addition of the curved design and changing the closing force of the clamps without any testing could significantly affect the safety and effectiveness of the device. Therefore, a new 510(k) is required for these changes.
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed. Our inspection also revealed design changes were made to your micro anastomosis clamps without notifying the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Our office requests that AROSurgical Instruments Corporation immediately cease activities that result in the misbranding or adulteration of the above-referenced surgical sutures and micro anastomosis clamps, such as the commercial distribution of the device for the uses discussed above.
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.
Your firm’s response should be sent to:
CAPT Daniel Cline
Acting Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
Refer to the identification number 452629 when replying. We remind you that only written communication is considered official. If you have any questions about the content of this letter please contact Dr. William Vitale, Compliance Officer at 949-608-2919.
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.
Alonza E. Cruse, Director
Los Angeles District
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413
Close Out Letter