Inspections, Compliance, Enforcement, and Criminal Investigations
Teleflex Incorporated 20-Jul-06
Department of Health and Human Services
Public Health Service
Atlanta District Officee
July 20,. 2006
VIA FEDERAL EXPRESS
Jeffrey P. Black, President & CEO
155 South Limerick Road
Limerick, PA 19468
Dear Mr. Black:
During an inspection of your establishment located at 2917 Weck Drive in Research Triangle Park, North Carolina, between March 21 and May 11, 2006, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures and distributes Kirschner Wires, Steinmann Pins, and Hem-o-lok Endoscopic Ligating Clip Appliers. 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), because they are intended for use 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 manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation for medical devices found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for finished device acceptance to ensure that each product run, lot, or batch of finished devices meets acceptance criteria, as required by 21 C.F.R. § 820.80(d). For example, during FDA's inspection, three lots of KMedic Steinmann Pins (K11793, K1 0822, and K11918) were selected at random from the released lots at your facility for examination by your quality assurance unit, and ail three lots failed this examination. Six pins were examined from Lots K11793, K10822, and K11918. All six pins failed the 15° and 30° angle check and the threads per inch specification for Lot K11793. All six pins failed the 30° angle check and one pin failed the 15° check for Lot K10822. One pin failed the 15° angle check and another failed the 30° angle check for Lot K11918. Lot K91918 had been inspected, packaged, labeled, and released by Tefeflex. Lots K11793 and K10822 had been inspected, packaged, labeled, and released to Teleflex by your supplier, Medic, in Northvale, NJ.
2. Failure to adequately maintain procedures to control product that does not conform to specified requirements, including a failure to evaluate the nonconformance, as required by 21 C.F.R. § 820.90(a). For example, your firm continued to release lots of Medic Kirschner Wire and Steinmann Pin lots that did not meet your finished product specifications. Furthermore, you did not conduct a complete evaluation of nonconformance; the evaluations should have included a determination of the need for an investigation into the nonconformance.
3. Failure to maintain procedures for implementing corrective and preventive action that include requirements for investigating the cause of the nonconformities relating to product, processes, and the quality system and for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 C.F.R. §§ 820.100(a)(2) and (3). For example, upon discovering problems with various lots of Medic Kirschner Wire and Steinmann Pins, as reported in Non-conformance Reports 505049157, 505064, 5050671505069, 505073, 505082, and 505086; your firm did not reevaluate and reinspect the lots that had been released for distribution to determine the extent and seriousness of the problem.
The investigation should have included tensile and elongation testing of all lots with nonconforming diameters and/or threads per inch counts. Testing should also have included functional testing with various corresponding instruments that are used with these products to ensure that they are still compatible. The investigation should also have included all Medic lots in storage at your facility. Inexplicably, no effort was made to reexamine any of the lots that had been packaged, labeled, and released at the Northvale facility. These were the exact same devices that had exhibited significant problems when examined prior to packaging at Teleflex. Without an examination of all of these lots you can not have a complete understanding of the scope of the problem with your firm's nonconforming products.
4. Failure to assure that the sampling plans in use were based on a valid statistical rationale and to ensure that sampling methods were adequate for their intended use, as required by 21 C.F.R. § 820.250(b). For example, your firm could not provide any rationale to support the sample sizes being utilized on incoming lots of Kirschner Wires. The sample size for some of the lots was reduced to [redacted] a sales unit, which is only [redacted] wires. This change was made during the time that nonconformities were being reported in several incoming lots. The incoming sample size for some of the lots was reduced to [redacted] sales units or [redacted] unit without any explanation or justification made for the change.
5. Failure to establish and maintain procedures for documenting and defining design output in terms that allows adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d). Your Medic Kirschner Wires and Steinmann Pins ere not designed to comply with the specified standards in ISO [redacted] particularly in regards to diameter and length. However, your firm continues to promote and market these products as meeting the ISO standards. Your firm's premarket notification (510(k)) submission also indicated that these products met ISO standards. When measurements were made during the inspection by your quality personnel on three released lots of Steinmann Pins at your facility, all three had failing results when compared to ISO dimensional specifications. All six pins failed in Lots K11793 and K10822. Three of six pins failed in Lot K11918. Your firm's internal specifications did not correlate with the ISO standards.
6. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 C.F.R. § 820.75(a). For example, your firm did not conduct reproducible qualification studies on the new molding process for Hem-o-lok Clips to include critical parameters such as [redacted] and pressure testing at both low and high process parameters. All of your test samples were taken from only the nominal setting to evaluate the new product.
Furthermore, your firm could provide no validation data as to the adequacy of the [redacted] ultrasonic aqueous degreasing and cleaning operation in procedure T4--001079. This procedure was used on Kirschner Wires and Steinmann Pins to remove particulates as noted on several nonconformance reports.
Our investigator collected a variety of Kirschner Wires and Steinmann Pins during the inspection and submitted them to FDA's Winchester Engineering & Analytical Center for analysis. Sample number 26733 consisted of 26 subs (each sub containing six devices) consisting of 156 pieces covering 9 different part and lot numbers. The pieces were submitted for dimensional measurements, visual examination, and comparison to your specifications. Forty nine out of 59 pieces examined dimensionally were found not in conformance with your release specifications In both the original and check analyses. In addition, 67 of 156 pieces visually examined were found to contain defects, including: blunt, bent, and irregularly shaped points; unevenly ground surfaces; and incorrectly shaped points and point angles.
Sample number 26732 consisted of 19 subs (each sub containing 6 pieces) for a total of 114 pieces. This included four different part and lot numbers. All pieces were visually examined. Twenty two of 32 pieces examined dimensionally were found not in conformance with your specifications in both the original and check analyses. In addition, 86 of 114 pieces visually examined were found to contain defects, including incorrectly ground flats, lips at flat edges, and flashing. A more detailed analysis of these results is included with this letter.
Our inspection also revealed that your Hem-o-lok Clips 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 C.F.R. Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
Failure to report within 30 days whenever a manufacturer receives or otherwise becomes aware of Information that reasonably suggests that a device marketed by the manufacturer has malfunctioned and such device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 C.F.R. § 803.50(a)(2). For example, your firm did not report Complaint 2006-286 concerning the Hem-o-lok Auto Endo 5, Lot 875569, remaining closed, even though similar events had been reported under the Medical Device Reporting requirement. Your firm also did not report Complaints 2006-139 and 2006-377 concerning closed Hem-o-lok Clips, which would not release from the applier jaw, even though similar events had been previously reported. These malfunctions should have been submitted to FDA within the required 30 day time frame.
We acknowledge receipt of a Teleflex Medical response to the Inspectional Observations from Don Harrison, Director of Global Supply Quality Assurance, dated June 1, 2006. Although your response appears to adequately address some of the observations, the response to several others appears to be inadequate. Our major concerns with the initial response include the inadequacy of the investigation performed into your nonconforming products, the determination that there is no risk associated with the use of these devices, the lack of detail involving the expanded validation studies for the Hem-o-lok Clip molding process, and the rationale for not reporting complaints under the Medical Device Reporting requirement. FDA will re-review your June 1, 2006 response in conjunction with your response to this letter.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 money penalties. Also, 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 wilt 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 violations, or similar violations, 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.
Your response should be sent to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you have any questions about this letter, you can contact Mr. Campbell at (404) 253-1280.
Finally, you should know that this letter is not intended to be an all-inclusive list of the 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 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.
Mary H. Woleske, Director