Tyco Healthcare Canada 2/14/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Avenue Silver Spring, MD 20993

WARNING LETTER

FEB 14 2011
 

VIA United Parcel Service {AND FACSIMILE}

Katherine Crewe
Plant Manager
Tyco Healthcare Canada
7500 Trans Canada Highway
Pointe-Claire, Canada

Dear Ms. Crewe:

During an inspection of your firm located in Pointe-Claire, Canada, on October 12, 2010, through October 15, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures saline and heparin vascular access flush syringes. 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 (OS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

Your response to the FDA 483 dated November 4, 2010, was not reviewed because it was not received within 15 business days from the issuance of the FDA 483. The response may be evaluated along with any other written material provided in response to violations cited in this Warning Letter. These violations include, but are not limited to, the following:

1. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).

For example, your firm's Installation/Operational Qualification Protocol System ID 33804B, Document Number V10M000072.IOQ, for the (b)(4) System ID 33804B, contains acceptance criteria for modifications to the (b)(4) (which (b)(4), and the (b)(4) However, validation results obtained:

A. Did not document that the (b)(4) and associated equipment met installation requirements as indicated in your firm's protocol;

B. Did not document that specifications for plunger defect rate, including acceptance criteria, met detection rates before modifications to the machine as required by your firm's protocol;

C. Did not document that the false positive rate met the specification of (b)(4)% for the 5/12 mL syringes as required by the protocol; and

D. Did not document that the detection rates of the new system performed better than the previous system. The new system had a detection rate of better than (b)(4)% for (b)(4) micron particles while the previous system had a detection rate of better than (b)(4)% for (b)(4) micron particles; the detection rates did not document that they met the USP requirements as required by your protocol, and your firm did not document testing for detection of (b)(4) micron particles, the USP requirements.

2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that shall include requirements for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR 820.100 (a)(5).

For example, SCAR report 09-090, dated December 11, 2009, stated that similar complaints of particles found in syringes have been reported lately and a strong preventive action is required. The corrective action was to require the vendor to use (b)(4) when shipping materials to the supplier location. However, the supplier documents the continuous use of (b)(4). Your firm has not ensured that the identified corrective action is being implemented by the supplier.

3. Failure to establish and maintain adequate procedures that define the responsibility for review and the authority for the disposition of nonconforming product, which shall include documentation of the justification for use of nonconforming product and the signature of the individual(s) authorizing the use, as required by 21 CFR 820.90(b)(1).

For example, your firm's non-conforming report states to specify condition/justification on impact of the quality. However, the following non- conforming material reports contained a disposition to "use as is" without either justification for use or documentation of impact on product as required by this form:

A. SCAR 10-033, dated March 4, 2010, was opened due to insects and foreign matter found in the pouches. Your firm's SCAR stated that several occurrences were already reported. However, the justification for "use as is" was (b)(4)% inspection during packaging but did not provide justification of using the pouches contaminated with insects and foreign matter for the disposition of "used as is".

B. SCAR 09-092, dated December 17, 2009, was opened due to large particles inside the syringes, which were received from the (b)(4) location in (b)(4). Although according to your firm's SCAR, this same issue was reported on December 14, 2009, the justification for "use as is" included (b)(4)% inspection of the prefilled syringe, and no impact on the quality of finished product.

C. SCAR 09-090, dated December 11, 2009, was opened due to large particles inside the syringes as in SCAR-092. Your firm's SCAR stated that three other complaints of the same nature have been reported lately and a strong preventive action is required. However, the justification for "used as is" stated that there was no impact on the quality of finished product because syringes go through the inspection machine and any defects are rejected.

A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.

U.S. 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 will 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. Please provide a translation of documentation not in English to facilitate our review.

Your response should be sent to: Field Operations Branch, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 2614, Silver Spring, Maryland 20903-0002. Refer to CMS case #159514 when replying. If you have any questions about the content of this letter please contact: Valerie A. Flournoy at 301-769-5770 or Fax: 301-847-8137.

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.
 

Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
 

Cc:
Kiley Herrick
US Designated Agent
Medical Supplies
15 Hampshire St.
Mansfield, MA 02048

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