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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sutures India Pvy. Ltd.

  

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

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

SEP 03 2010
 

WARNING LETTER

VIA United Parcel Service

Mr. L.G. Chandrasekhar
Chairman
Sutures India Pvy. Ltd.
472 D, 13th Cross, 4th Phase
Peenya Industrial Area
Bangalore, Karnataka, 560058
India

Dear Mr. L.G. Chandrasekhar:

During an inspection of your firm located in Bangalore, Karnataka, India, on April 19 through 23, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sutures. 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, their manufacture, 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 (CFR), Part 820. Your firm did not submit a response concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations, that was issued to you. These violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate 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:

a. Your firm does not maintain adequate Design History Files for the Trusynth, PDSynth and Trulene Mesh - absorbable and nonabsorbable products. Your firm did not document the following:
 

i. Design Inputs
ii. Design Outputs
iii. Design review
iv. Design Transfer
v. Design Change

b. Your firm's Design and Development procedure, QP/QA/11, Issue 01, Rev. 00, states "Sutures India does not need any requirement for design control for its' present range of products and therefore has no Design and Development Department."

2. Failure to validate and approve a process whose results cannot be fully verified by subsequent inspection and test with a high degree of assurance according to established procedures, as required by 21 CFR 820.75(a).

For example, your firm does not have validation procedures and does not have validation data for the Class (b)(4) and (b)(4) clean rooms used to manufacture Trusynth, PDSynth and Trulene Mesh suture products. Your firm only verifies that the clean rooms maintain particle thresholds in the way of a contract testing firm collecting samples on a (b)(4) basis to ensure a lower particle threshold is maintained.

3. Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules and failure to document the inspections, including the date and individual(s) conducting the inspections, as required by 21 CFR 820.70(g)(2).

For example, your firm did not conduct (b)(4) maintenance for the (b)(4),as required by Sec No: QP/MNT/02 of the Quality System Procedure Maintenance (Preventive and Breakdown), but conducted maintenance (b)(4) on (b)(4) and (b)(4). In addition, the procedure does not list a maintenance schedule for the other

4. Failure to establish and maintain adequate procedures to control all documents and provide for document approval and distribution by designating an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part; failure to have documents established to meet the requirements of this part available at all locations for which they are designated, used, or otherwise necessary; and failure to promptly remove obsolete documents from all points of use or otherwise prevent them from unintended use, as required by 21 CFR 820.40(a). For example:

a. The Master List of Documents, Quality Control, F/DDC/01, Issue 01, Rev 03, supplied during the inspection was obsolete. The revision number of the documents listed in the Master List of Documents did not match the revision numbers of the documents contained in the Quality Control supervisor files:
 

Quality Control Supervisor
Master List
WI/QC/RM-02, Issue 01, Rev 05
WI/QC/RM-02, Issue 01, Rev 03
WI/QC/RM-21, Issue 01, Rev 00
WI/QC/RM-21, Issue 01, Rev 01
WI/QC/FP-06, Issue 01, Rev 01
WI/QC/FP-06, Issue 01, Rev 00
WI/QC/MB-01, Issue 01, Rev 03
WI/QC/MB-01, Issue 01, Rev 00
WI/QC/TM-03, Issue 01, Rev 01
WI/QC/TM-03, Issue 01, Rev 00

 
b. The Master List of Documents, Quality Control, F/DDC/01, Issue 01, Rev 03, which lists documents that are in use, was missing issue numbers, issue dates, revision numbers, revision dates and number of copies as required by Document Control procedure, QP/MR/03, Issue 01, Rev 4, for the following documents:
 
1) WI/QC/PM-02: Specification and Test Methods for Medical Grade Kraft Paper
2) WI/QC/PM-03: Specification and Test Methods for Tyvek/Coated Tyvek
3) WI/QC/MB-08: Estimation of Bacterial Count in Biological Indicator Strips
4) WI/QC/TM-02: Determination ofIn Vitro Basic Strength Retention Test
5) WI/QC/TM-03: Determination Of Knot Security Test For Synthetic Absorbable Sutures
6) WI/QC/TM-06: Suture Pull out Strength Test
 
c. The procedures reference forms that do not match the titles of the forms used during manufacturing. Also, the following forms do not contain the form numbers that are referenced in the procedure:
 
 
i. Customer Complaint/Comment Reporting Format form used to document details of incoming complaints as referenced from your firm's Handling of Customer Complaints Procedure, QP/MKT/04, Issue 01, Rev 02.
ii. Training Matrix Form used by Human Resource Department to document training for firm's employees as referenced by your firm's Training Process Procedure, QP/PER/01, Rev 02.
iii. Training Attendance Sheet used by Human Resource Department to document attendance of training given and is referenced by your firm's QP/PER/01, Issue 01, Rev 02.
iv. Supplier Questionnaire Form used by Purchasing Department to collect information for preassessment of vendors as referenced by your Purchase Procedure, QP/COM/01, Rev 03.
 
5. Failure to maintain adequate device master records (DMRs) for each type of device that include or refer to the location of quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used, as required by 21 CFR 820.181(c). For example, your firm does not include orrefer to the location of Quality Assurance Procedures or specifications for the Trusynth, PDSynth and Trulene mesh in the Device Master Record.
 
6. Failure to establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the Quality System regulation, as required by 21 CFR 820.184. For example, your management stated that they did not have any Device History Record procedures.
 
Our inspection also revealed that your suture 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) regulation. Significant deviations include, but are not limited to, the following:
 
A follow up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
 
Given the serious nature of the violation(s) of the Act, sutures manufactured by your firm 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 may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Waming Letter as described below and correct the violation(s) described in this letter. We will notify you if your response is adequate, and we will proceed to schedule a follow up inspection of your facility to verify that the appropriate corrections have been made, as described in the preceding paragraph.
 
Also, US. 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 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. 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action 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. Please provide a translation of documentation not in English to facilitate our review.
 
Your response should be sent to: Mr. Thomas C. Knott, 10903 New Hampshire Ave., Building 66, Room 3520, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact: Mr. Knott at 301-796-5770 or fax: 301-847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
 
Sincerely yours,
/S/
Larry D. Spears
Deputy Director of gulatory Affairs
Office of Compliance
Center for Devices and
   Radiological Health