- F.P. Rubinstein Y Cia SRL
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
JAN 29, 2015
VIA UNITED PARCEL SERVICE
Rodolfo C. Tozzi
F.P. Rubinstein Y Cia SRL
David Luque 519
Dear Mr. Tozzi:
During an inspection of your firm located in David Luque 519, Corboda, Argentina, on October 14, 2014, through October 17, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures dermabrasion, hair removal, radiofrequency skin lifting, and ultrasonic dermal peeling devices. 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 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 Francisco Giralt, Manager Representative dated November 7, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response 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 ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, and to document design review, including identification of the design, the date, and the individuals performing the review, in the design history file (DHF), as required by 21 CFR 820.30(e). For example:
a. Your firm does not have procedures for design reviews.
b. Your firm has not performed or documented design reviews in the DHF for the RC Six Power Basic radiofrequency skin lifting device.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not include evidence of implementation of corrective actions. In addition, your firm did not conduct a retrospective review of design files to ensure that the design reviews are adequately implemented.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm’s nonconforming product procedure, PG 02, Rev. 2, requires analysis of quality problems to identify the real or potential causes of nonconformance. However, your firm has not performed an evaluation of nine nonconformance reports.
We reviewed your firm’s response and conclude that it is not adequate. Your firm plans to generate appropriate documentation with an investigation plan. However, your firm did not specify which documents will be generated or revised to address this observation. You firm did not address how it will confirm the effectiveness of corrective actions. In addition, your firm did not conduct a retrospective review of other nonconformance reports to ensure that the nonconformances are evaluated and controlled in accordance with your firm’s procedure.
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm has not processed complaints in accordance with its complaint handling procedure, PG 03, Rev. 0. Specifically:
a. Your firm has not been evaluating complaints to determine if they are reportable under 21 CFR 803 (Medical Device Reporting).
b. Your firm has not evaluated and investigated the following complaints: case numbers (b)(4) and (b)(4).
c. Your firm has not recorded complaints in (b)(4) system.
d. Your firm has not given a unique identifier for nine complaints recorded on a Word document. Additionally, two of nine complaints were missing contact information.
The adequacy of your firm’s response cannot be determined at this time. Your firm did not provide evidence of implementation of corrective actions specific to this observation.
4. 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:
a. Your firm's design change procedure, (b)(4), requires design changes to be documented on form (b)(4). However, your firm implemented design changes for the RC Six Power R radiofrequency skin lifting device without completing the form.
b. Your firm’s design change forms for application numbers (b)(4) and (b)(4) are incomplete. Specifically, the forms had documentation missing in the following sections: (b)(4) In addition, the design changes were implemented without a signature of approval.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not conduct a retrospective review of design files to ensure that the design changes are adequately implemented.
5. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, device history record form HS6100, for lot number 03, serial number 1008, was not signed for release. However, the shipping section of HS6100 was completed on March 10, 2013, indicating that your firm shipped unreleased devices to a customer.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its acceptance procedure, PE 06.02. However, your firm did not provide the revised procedure. In addition, your firm did not address how it will ensure that the finished device acceptance activities are adequately established.
6. Failure to document all corrective and preventive action (CAPA) activities and their results, as required by 21 CFR 820.100(b). For example, your firm’s CAPA reports are incomplete. Specifically:
a. CAPA Number NCAI3 13-3 had the following sections incomplete: “Corrective and Preventive Actions,” “Implementation,” “Verification,” “Impact of Actions,” and “Effectiveness of the Solution.”
b. CAPA Numbers NCAI6 13-3, NCAI5 13-3, NCAI8 13-3 and 140501 had the following sections incomplete: “Impact of Actions” and “Effectiveness of the Solution.”
c. CAPA Numbers NCAI1 13-3, NCAI2 13-3, NCAI3 13-3, NCAI5 13-3, NCAI6 13-3, NCAI8 13-3, and 140501 were not signed as complete or closed.
We reviewed your firm’s response and conclude that it is not adequate. Your firm plans to generate or revise appropriate documentation. However, your firm did not specify which documents will be generated or revised. In addition, your firm did not provide any revised documents.
7. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example, your firm's calibration procedure, (b)(4) requires equipment to be calibrated annually. Your firm’s calibration form, PL06.02.001, lists all the equipment requiring calibration. The date of the last calibration for all equipment was July 4, 2013. According to the form, the due date for the next calibration for equipment (b)(4) and (b)(4) was July of 2014. However, equipment (b)(4) and (b)(4) were not recalibrated as required.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s corrective action plan does not ensure that the compliance with calibration requirements will be maintained. Your firm did not provide evidence of the documents revised for this observation. In addition, your firm did not conduct a risk assessment on the devices that were processed though non-calibrated equipment.
8. Failure to designate individuals to review for adequacy and approve prior to issuance all documents established to meet the requirements of 21 CFR 820, as required by 21 CFR 820.40(a). For example, your firm’s instruction document for (b)(4), was not signed as reviewed and approved prior to issuance. However, these instructions are being used for your firm’s (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not indicate whether your firm plans to retrospectively review quality system documents to ensure that the documents are approved prior to implementation. Your firm did not provide evidence of implementation of its corrective actions.
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including dermabrasion, hair removal, radiofrequency skin lifting, and ultrasonic dermal peeling devices, 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 is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, U.S. 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 deviations are reasonably related will not be approved until the violations 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, including 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. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #445870 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 (301) 796-5587 or fax +1 (301) 847-8139.
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
Agustin Caunedo, Jr.
Starbene USA, Inc.
2030 N.W. 94th Avenue
Miami, Florida 33172