Inspections, Compliance, Enforcement, and Criminal Investigations
Sutures India Pvy. Ltd.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
SEP 03 2010
VIA United Parcel Service
Mr. L.G. Chandrasekhar
Sutures India Pvy. Ltd.
472 D, 13th Cross, 4th Phase
Peenya Industrial Area
Bangalore, Karnataka, 560058
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
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:
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
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.
Larry D. Spears
Deputy Director of gulatory Affairs
Office of Compliance
Center for Devices and