Inspections, Compliance, Enforcement, and Criminal Investigations
Thinking Systems Corp. 07-Jan-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
January 7, 2005
Xiaoyi Wang, President
Thinking Systems Corp.
780 94th Avenue N .
St. Petersburg, Florida 33702-2468
Dear Mr. Wang:
During an inspection of your establishment located at 780 94th Avenue N., St. Petersburg, Florida on November 15-17, 2004, an FDA Investigator determined that your firm manufactures picture archiving and communications software for Nuclear, Echo and Cath Lab Cardiology Medicine applications, which are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. 321(h)].
The investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), part 820 and part 803. These violations cause the device(s) you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] and misbranded within the meaning of Section 502(t)(2) [21 U.S.C. 352(t)(2)] of the Act.
The investigator noted the following violations of the QS regulations:
1. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization as required by 21 CFR 820.20. Your firm has not established, implemented and maintained an effective quality system at all levels of your organization including a Corrective and Preventive Action (CAPA) procedure, an Internal Audit procedure, a Management Review procedure, a Quality Policy, and a Quality Plan that defines quality practices, resources and activities (FDA 483, Item #1 & 2).
2. Each manuf.Acturer shall 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. Your firm has not established and implemented procedures to conduct quality audits nor have you conducted quality audits to verify that your quality system is effective (FDA 483, Item #1).
3. Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action (CAPA) as required by 21 CFR 820.100(a). Your firm lacks a written CAPA procedure and there are no established requirements to verify/validate that CAPA is effective prior to implementation and not detrimental to the finished device (FDA 483, Item #3).
4. Corrective and preventive activities required by 21 CFR 820.100 and their results shall be documented as required by 21 CFR 820.100(b). The MDStation release bug reports noted from June 24, 2000 to November 4, 2004 requiring corrective action were not documented including the investigation, implementation of CAPA and the verification/validation of the action taken (FDA 483, Item #8).
5. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until all acceptance activities are completed as required by 21 CFR 820 .80(d). No acceptance procedures have been established requiring documentation of final acceptance activities and the final validation testing for the Thinkingnet system has not been documented. 21 Thinkingnet systems produced since July 2001 have been distributed (FDA 483, Item #9).
6. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40 as required by 21 CFR 820.181. No DMR has been established for the Thinkingnet system (FDA 483, Item #6).
7. Each manufacturer shall maintain device history records (DHR's). Each manufacturer shall establish and maintain procedures to ensure that DHR's for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR~as required by 21 CFR 820.184. Your DHR does not include or refer to production dates, acceptance records, and labeling for the Thinkingnet systems produced from July 2001 to November 17, 2004 (FDA 483, Item #7).
Medical Device Reporting(MDR)
Your devices are misbranded within the meaning of section 502(t)(2) in that there was a failure to comply with a requirement prescribed under section 519 of the Act respecting the device as follows:
8. Your firm failed to establish and maintain written MDR procedures as required by 21 CFR 803.17 (FDA 483, Item #5).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. 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. We have reviewed your response dated November 17, 2004 and find that the response is inadequate because it only promises to make the necessary corrective actions. Also for new or updated procedures, there was no evidence that these documents have been implemented and are effective. The investigator also annotated all of the FDA 483 observations as "Promised to Correct". There was no mention that any of your corrective actions were "Corrected and Verified" . You should address each and every observation when responding to this letter. Your response has been made part of the Florida District file.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be sent to Timothy J . Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Director, Florida District