Company: Torbot Group Inc., Jobskin Division
Subject: CGMP/QSR/Medical Devices/Adulterated
Issuer: Cincinnati District Office
Issued: April 14, 2008 Closed:
Not applicable.
Source ucm1048343 Archive Code:

Torbot Group Inc., Jobskin Division 14-Apr-08

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX : (513) 679-2771

April 14, 2008



Sharon Yarlas
Torbot Group Inc., Jobskin Division
1367 Elmwood Avenue
Cranston, RI 02910

Dear Ms. Yarlas:

During an inspection of your firm located in Toledo, OH, on January 28 through February 14, 2008, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures compression garments for burn victims and to treat lymphedema vascular conditions. 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 are intended 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 manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:

1) Failure to implement your corrective and preventive procedures to assure the sources of quality data are analyzed to identify existing and potential causes of nonconforming product or other quality problems. [21 C.F.R. § 820.100(a)] Specifically,

a) Failure to analyze internal failures, supplier issues/audits, and complaints to identify trends and determine if a failure investigation was needed, as required by your Corrective and Preventive Action procedure.

b) The following three trends in quality data sources were no identified and Form 54826 (Action Request Form) has not been initiated to investigate these trends:

-A total of 467 of the [redacted] medical devices (garments and vests) manufactured between 11/5/2007 and 2/6/2008 required internal rework. These reworks have not been trended, no investigation has been performed, and no corrective action has been taken.
-A total of 36 of the 210 complaints on the Glove to Wrist device (item 59110535) were returned due to the wrong product being shipped . This trend was not identified, no investigation was performed, and no corrective action was taken.
-A total of seven of the last 20 [redacted] (the main components to all your devices) failed specification. This nonconformance was not investigated.

2) Failure to document corrective and preventive action activities, including analysis of sources of quality data, investigations of causes of nonconformities, the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, implementation of corrective and preventive actions, and dissemination of information about quality problems or nonconforming product to responsible parties. [21 C.F.R. § 820.100(b)]

Specifically, your Operations Manager and Systems Manger stated that you are actively seeking and testing material from other potential suppliers of the fabric used to make your devices due to incoming fabric failures. Your Corrective and Preventive Action procedure was not followed, in that the Action Request Form (Form 54826) was not completed to document the investigation into these fabric failures and the evaluation of new suppliers. The only documentation for these actions is e-mails and tests results received from potential suppliers .

3) Failure to establish procedures for finished device acceptance to ensure that each production run, lot or batch of finished devices meets acceptance criteria. [21 C.F.R. § 820.80(d)]

Specifically, the patient measurements of the custom made head, neck, chest, arm, and hand burn and vascular/lymphedema garments are not verified.

4) Failure to establish requirements, including quality requirement that must be met by suppliers. [21 C.F.R. § 820.50(a)].

Specifically, requirements for the [redacted] the main component of the device, have not been established. Additionally, a trend in fabric test failure has been identified and you have not performed a supplier evaluation since you took ownership of this firm in 2003.

5) Failure to ensure that a Device Master Record was prepared and approved for each type of medical device your firm manufactures. [21 C.F.R. § 820.181]

Specifically, your firm does not have a Device Master Record that contains or references all of the drawing and production specifications, production procedures, quality assurance procedures, packaging and labeling specifications for each type of device manufactured.

6) Failure to demonstrate in the device history record that the device s manufactured in accordance with the device master record. [21 C.F.R. § 820.184]

For example, the device history records for the vascular/lymphedema devices do not contain a copy of the primary identification label.

7) Failure to demonstrate that the design was developed in accordance with the design control requirements of the QS regulation; and failure to establish a Design History File. [21 C.F.R. § 820.30(a) through (j)]

For example, the design controls for the vascular/lymphedema compression garments are inadequate because of deficiencies including, but not limited to, the following: (1) a design plan identifying and describing interfaces with different groups or activities was not developed; (2) the design inputs were not established; (3) the design outputs that are essential for proper functioning of the software are not identified; (4) the verification testing has not been performed to show that the design output meets the design input requirements; (5) a formal document review of the design results has not been conducted and the results have not been documented; (6) design validation has not been performed to ensure design specifications conform with user needs and intended use(s); and design transfer. See 21 C.F.R. §§ 820.30(b), (c), (d), (e), (f), (g) and (h).

8) Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate verification, review, and approval of design changes before their implementation. [21 C.F.R. § 820.30(i)]

9) Failure to implement your management review procedure, [21 C.F.R. § 820.20(c)]

Specifically, since taking ownership of the company in 2003, you have not conducted an annual management review.

10) Failure to implement your procedure that assures that environmental conditions that could reasonably be expected to have an adverse effect on product quality be adequately controlled. [21 C.F.R. § 820.70(c)]

Specifically, your "Conditioning and Test Environment for Textiles" procedure requires that the recorder chart be reviewed to assure that humidity and temperature were within specification when the testing was performed. This review is not being completed and documented.

Our inspection also revealed that the Thoracic Vest and Carissa garments are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), in that they were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j). You did not list these devices, as required by 21 CFR 807.20(a).

You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices to which the Quality System regulation deficiencies 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 within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct these noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation for the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.

Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations to bring your products into compliance.



Carol A. Heppe
District Director
Cincinnati District

Cc: Gregory L. Johnson
General Manager
Torbot Group Inc., Jobskin Division
653 Miami Street
Toledo, OH 43605