FDA Warns Sometech Inc. for CAPA, Design Procedure and Customer Complaint Handling Violations

  • By: Staff Editor
  • Date: April 11, 2011
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South Korean medical device manufacturer Sometech Inc. has been sent a warning letter by the FDA on April 6, 2011, for inadequate, non-compliant CAPA, customer complaint handling and design documentation procedures, among other violations.

An FDA inspector visited the company from November 1 through November 4, 2010.  In the subsequent Form 483, the inspector noted around 18 observations of regulatory non-compliance. Sometech’s responses to each of the observations were considered unsatisfactory and the agency sent the warning letter, stating that it considered Sometech’s products “adulterated” as the methods, facilities and controls used for manufacturing, packing, storage and installation were not in conformity with cGMP requirements of the Quality System (QS) regulation 21 CFR Part 820.

CAPA Procedure Violations

During discussions at the inspection site, the FDA inspector highlighted the firm’s failure to adequately establish and maintain procedures for implementing CAPA. Sometech was found to have no requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. The FDA inspector reviewed the five CAPAs initiated in 2009 and 2010 for US devices Lysos, Dr Oppel, Dr Camscope and Dr Highscope and found them deficient with regard to nonconformity, corrective actions needed, verification and implementation and recording of changes.

Sometech also approved a CAPA procedure in 2009 prior to the completion of implementing and recording changes in methods and procedures needed to correct and prevent identified problems. The investigation of the nonconformity cause determined that the supplier of the bracket used in the manufacture of Dr. Highscope device did not meet specifications. The firm was asked to add the bracket to the list of receiving acceptance activities – a requirement that was not completed at the time of inspection.

Other Regulatory Violations

In addition to these CAPA-related irregularities, the FDAer cited the following  violations on the part of Sometech:

  • Inadequate Complaint Handling Procedures: Sometech did not have systems in place to review and evaluate complaints for possible investigations. Its SOP for complaint handling did not require recording of decisions to not investigate complaints and who was responsible for making them. Sometech did not record names and addresses of complainants and the dates of their complaints.
  • Non-compliant Design Input Requirements: Sometech’s design input requirements SOP was found to be inadequate as it did not include review and approval by a designated individual. The firm had not documented the first set of design inputs for the LVT100 design project.
  • Non-compliant Design Output Procedures - The LVT100 design project also did not have an established acceptance criteria. Project documentation did not identify design outputs essential for proper functioning of the device. It did not require documentation of output approval and date and signature of the individual approving the output.
  • Improper Design Review Procedures - The LVT100 design project was again cited for faulty design review procedures. Specifically, a meeting held on July 20, 2008 was named as the final design review meeting for the LVT100 design project and did not include an individual who did not have direct responsibility for the stage being reviewed as required by regulations. The meeting itself was conducted prior to any design validation activities.
  • Faulty Design Verification Procedures - Sometech’s design verification procedure did not confirm that design output met design input requirements. Sometech had conducted only one design verification activity on August 09, 2008 for the LVT100 design project. A protocol was not established prior to the conducting of any design verification activities. The documentation for this activity did not include the date and details of individuals performing the verification.
  • Inadequate Design Validation – Device inspection record documents for the LVT100 project did not reference the serial numbers of the device used in validation activities. Sometech was unable to demonstrate that these design validation activities were performed on initial production units, lots or batches or their equivalents. Although the person responsible stated that initial production units were used in both validations, DHRs were not maintained.
  • Non-compliant Design Changes Procedure - Somtech’s design changes procedure did not define procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of both pre- and post- production design changes before their implementation. The firm’s logo was removed from the LVT100 case on July 10, 2008 but there is no documentation for any validation or verification activities for this change.
  • No Design History File - Sometech did not establish and maintain an adequate design history file. The approved drawings of parts used in the manufacture of LVT100 were not included in the design history file for the LVT100 design project.
  • Inadequate Control of Environmental Conditions - The firm did not establish procedures for monitoring electrostatic discharge devices used during the handling of, among other things, printed circuit boards.
  • Inadequate Acceptance Procedures – Sometech did not establish and maintain adequate acceptance procedures, where appropriate, to ensure that specified requirements for in-process product were met. It did not validate the soldering process used in the manufacture of Dr. Oppel ST-501 device.
  • Inadequate Procedures to Document Acceptance Activities – There were no procedures for verification activities to include the name of the individual conducting the verification activity and the date the activity was conducted.
  • No Calibration Dates Displayed – Sometech did not establish and maintain adequate procedures to ensure that the next calibration dates for equipment were documented and displayed on or near each piece of equipment.
  • Faulty Sampling Methods - The firm was unable to provide a statistical rationale for sampling LVT100 units used in the validation activities to comply with domestic standards for medical devices.
  • No Documentation of Audit Dates – Sometech’s Internal Audit Procedure dated July 14, 2003, did not define that the dates of quality audits and re-audits be documented.
  • Faulty Training Procedures - The firm's training record for quality auditors documented the training assessment of two individuals but Sometech was unable to demonstrate which individual completed the training assessment.
  • Inadequate Device History Recording Procedures - Three of three DHRs reviewed (for LVT100, Dr Camscope and Dr Oppel) did not include or refer to the location of the dates of manufacture. Dr Camscope and Dr Oppel DHRs did not include complete acceptance records which demonstrate the device is manufactured in accordance with the DMR. All three DHRs reviewed did not include device identifications and control numbers used. These DHRs did not include the date the lots were released for distribution.
  • No MDR Procedures - The firm violated MDR regulations by having no Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.

Sometech has been warned that given the serious nature of the violations, all devices manufactured by the 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. 



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