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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Syntee Scientific Corp. 30-Sep-05

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

Public Health Service
Food and Drug Administration

 

Center for Devices and Radiological Health
2098 Gaither Road
Rockville, MD 20850


 

September 30, 2005

WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Charles Chang
President
Syntec Scientific Corp.
2 Kung San Road
Chuan Shing Industrial Zone
Shen Kang, Chang Hua
Taiwan, Republic of China

Dear Mr. Chang:

During an inspection of your firm located in Chang Hua, Taiwan, on May 2-5, 2005, our investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-sterile stainless steel orthopedic screws and plates to be used in trauma cases. These products are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).

This inspection revealed that these devices appear to be 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 Regulation (CFR), Part 820. Significant violations include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for documenting the disposition of nonconforming product, as required by 21 CFR § 820.90(b)(1). Specifically, there is no documentation of the disposition of nonconforming product. For example,

a. There is no documentation of the disposition of [redacted] pieces of [redacted] hole quarter tubular plates, purchase order number [redacted] returned from customer for out-of- specification plate width results as reported.

b. There is no documentation of the disposition of [redacted] pieces of [redacted] hole left [redacted] L-Buttress Plates, purchase order number [redacted] returned from customer for out-of-specification results when measuring the plate in an overlay as reported.

c. There is no documentation of the disposition of [redacted],pieces of [redacted] [redacted] hole quarter tubular plates, purchase order number [redacted] returned from customer for out-of-specification hole width results as reported.

2. Failure to establish and maintain adequate acceptance procedures to ensure that specified requirements for in-process product are met, as required by 21 CFR § 820.80(c). Specifically, your firm does not adhere to the acceptance procedures for ensuring that specified requirements for in-process product are met. For example,

a. Production Progress Daily Report for [redacted] pieces made on [redacted] of product number [redacted] indicates pieces rejected due to break in tooling; however, the in-process inspection record does not show inspection and measurements for the first article after the tooling was repaired, as specified in the [redacted] In-process Quality Inspection Control Procedure."

b. Production Progress Daily Report for [redacted] pieces produced on [redacted] of product number [redacted] indicates [redacted] pieces rejected due to bad threading; however, the in-process inspection record does not show inspection and measurements for the first article after tooling adjustment was made, as specified in the'[redacted] In-process Quality Inspection Control Procedure."

c. Production Progress Daily Report for [redacted] pieces produced on [redacted],of product number [redacted] indicates [redacted]pieces rejected due to bad threading; however, the in-process inspection record does not show inspection and measurements for the first article after tooling adjustment was made, as specified in the [redacted] In-process Quality Inspection Control Procedure."

d. Production Progress Daily Report for [redacted] pieces produced on [redacted] of product number [redacted] indicates [redacted]pieces rejected due to bad drilling; however, the in-process inspection record does not show inspection and measurements for the first article after tooling/drilling was changed, as specified in the [redacted] In-process Quality Inspection Control Procedure."

3. Failure to have process controls include criteria for workmanship that must be expressed in documented standards or by means of identified and approved representative samples, as required by 21 CFR § 820.70(a)(5). Specifically, there is no documentation that the operator self-inspections of appearance/machining results during processing are conducted according to identified and approved representative samples. Section [redacted] Self Inspection, of the [redacted] In-process Quality Inspection Control Procedure" does not include operator instructions for how many or how often inspections should be conducted.

4. Failure to establish and maintain adequate procedures for acceptance of incoming product, as required by 21 CFR § 820.80(b). For example, you accept stainless steel rods and sheets from two different vendors with only a certificate of analysis for each product. Your firm does not test the properties of these products or verify that the products meet the specifications indicated on the certificate.

The inspection also revealed that your devices are misbranded within the meaning of section 502(t)(2) of the Act (2l U.S.C. § 352(t)(2)), in that your firm failed to furnish information to the Food and Drug Administration (FDA) as required under section 519 of the Act and regulations implementing that section at 21 CFR Part 803, Medical Device Reporting.

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR § 803.17. Specifically, you have not developed and implemented written MDR procedures.

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 List of Inspectional Observations, Form FDA 483, which was issued at the closeout of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and you must take prompt action to correct the violations and to bring your products into compliance.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 38l (a)).

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 violations, or similar violations, from occuring again. Include all documentation of the corrective action you have taken. If you plan to make any corrections in the future, include those plans with your response to this letter as well. If the documentation is not in English, please provide a translation to facilitate our review.

Your response should be sent to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement B, Orthopedic, Physical Medicine & Anesthesiology Devices Branch, 2098 Gaither Road, Rockville, Maryland 20850 USA, to the attention of Mr. William C. MacFarland.

If you need help in understanding the contents of this letter, please contact Mr. William C. MacFarland at the above address, telephone (240) 276-0120, or telefax (240) 276-0325.

/Sincerely/

Timothy A. Ulatowskil
Director
Office of Compliance
Center for Devices and Radiological Health