Inspections, Compliance, Enforcement, and Criminal Investigations

A.R.C.O.S. Srl 8/3/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

 

WARNING LETTER
AUG 3, 2016
 
VIA UNITED PARCEL SERVICE
 
Giulio M. Cortinovis
President
A.R.C.O.S. Srl
Via Dell Artigianato 47
25039 Travagliato, Brescia
Italy
 
Dear Mr. Cortinovis:
 
During an inspection of your firm located in Travagliato, Brescia, Italy,on April 4, 2016, through April 6, 2016, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures compression socks. 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 you dated April 22, 2016, concerning our investigators’ 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 control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm does not have written design control procedures, and has not conducted and documented design control activities for various models of compression socks, including TRAVELSOX, EUROS, CARESOX, and VITALSOX.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create design control procedures and design history files. However, there is no indication your firm plans to evaluate the potential impact of the lack of design controls on previously distributed devices.
 
2.    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 does not have written complaint handling procedures and does not conduct investigations into complaints received directly or by your firm’s U.S. agent.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create email addresses for its complaint handling department and complaint handling procedures. However, there is no indication your firm plans to evaluate any complaint files for previously distributed devices.
 
3.    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 does not have written nonconforming product procedures.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create nonconforming product procedures. However, there is no indication your firm plans to evaluate the potential impact of the previous release of nonconforming product. 
 
4.    Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, your firm does not have written procedures that define and control the manufacturing processes for various models of compression socks, including TRAVELSOX, EUROS, CARESOX, and VITALSOX.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create manufacturing process procedures. However, there is no indication your firm plans to evaluate the potential impact of the lack of process controls on previously distributed devices.
 
5.    Failure to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a). For example, your firm does not have written procedures for receiving, in-process, and final acceptance activities. Additionally, your firm conducts pressure testing on compression socks as part of final acceptance. Pressure testing is conducted using different calf and thigh former girths than specified in the equipment manufacturer’s instructions. However, no justification is documented for this change to the test process.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create procedures and contact the equipment manufacturer (b)(4) in a manner not specified in the instructions. However, there is no indication your firm plans to evaluate the potential impact of inadequately documented acceptance activities for previously distributed devices.
 
6.    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 21 CFR Part 820 and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). For example, your firm does not have written management review procedures and does not document management reviews.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated it will create management review procedures and conduct management reviews. However, documentation of these corrective actions has not been provided for review.
 
7.    Failure to establish and maintain 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, your firm does not have written purchasing control procedures.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create purchasing control procedures. However, there is no indication your firm plans to evaluate the potential impact of the lack of supplier controls on previously distributed devices.
 
8.    Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm does not have written CAPA procedures and does not maintain CAPA records.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create CAPA procedures. However, there is no indication your firm plans to use the new CAPA procedure to evaluate any existing quality data.
 
9.    Failure to establish 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. For example, your firm does not have written internal quality audit procedures and has not conducted internal quality audits.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated it will create internal quality audit procedures and conduct internal quality audits. However, documentation of these corrective actions has not been provided for review.
 
10.    Failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a). For example, your firm conducts pressure testing on compression socks as part of final acceptance. Testing is performed (b)(4). However, sampling is not based on a valid statistical rationale.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated it will create procedures. However, there is no indication your firm plans to establish sampling plans based on valid statistical rationale for conducting acceptance activities.
 
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR).  Significant violations include, but are not limited to, the following:
 
11.    Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, there are no procedures to govern adverse event reporting.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated it will create procedures and an electronic MDR account. However, documentation of these corrective actions has not been provided for review.
 
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the compression socks, 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, Room 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #500510 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcment Branch, at feb@fda.hhs.gov (email), +1(240) 402-4020 (telephone), or +1(301) 847-8138 (fax).
 
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. 
 
 
Sincerely yours,
/S/                                                                                   
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and
Radiological Health
 
 
Cc:
U.S. Agent
Sockwise, Inc.
4575 South Coach Drive
Tucson, Arizona 85714

Page Last Updated: 08/08/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English