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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Tyco Healthcare Group 22-Aug-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


August 22, 2005


Richard J. Meelia
Tyco Healthcare Group
15 Hamshire Street
Mansfield, MA 02048

Dear Mr. Richard Meelia:

During an inspection of your firm located in Galway, Ireland (Nellcor Ireland) on February 28, 2005, through March 3, 2005, our investigator determined that your firm manufactures a number of products including, but not limited to, ventilator, pulse oximetry, and oxygen therapy products. 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 Regulations (CFR), Part 820. Significant violations include, but are not limited to, the following:

1. Failure to establish and maintain procedures for the validation, or where appropriate verification, of design changes before their implementation, as required by 21 CFR 820.30(i).

For example, your firm's Design Verification procedure [redacted] Design Validation procedure [redacted] and Change Control procedure, [redacted] do not specify criteria for determining when design verification is sufficient in lieu of validation. The Change Control procedure broadly states that changes in user functionality or intended uses requires design validation but no specific criteria are established for determining when design validation is required.

2. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b).

For example, the Incoming Inspection Records for [redacted] for the [redacted] do not demonstrate that all samples were inspected or tested in accordance with the Incoming Inspection Procedure [redacted]. In addition, there was no documentation to show the 100% inspection results for [redacted], an [redacted] for the [redacted].

3. Failure to establish and maintain acceptance procedures to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c).
For example:

a) The Product History Records for the [redacted] did not document the actual voltage and resistance measurements taken during the [redacted], The [redacted] Functional Test procedure, [redacted] requires voltages and resistance measurements be taken with [redacted]. There was no documentation of the actual measured value for voltage and resistance in the Product History Records. These results were reflected in the Product History Record (Device History Record) for the parent or system test, i.e., [redacted]

b) The [redacted], [redacted], [redacted] does not require that the voltage and resistance measurements be documented.

4. Failure to establish and maintain procedures to ensure that complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1).

For example, our investigator observed that failure investigations have not been processed and closed in a timely manner. Nellcor Ireland receives complaints related to its manufacturing site from the [redacted] in [redacted]. The [redacted] receives and reviews all complaints and closes the complaints by creating a Complaint Investigation ID CAPA. The respective manufacturing site completes the failure investigation and the results of the failure investigation are used to determine if it supports closure of the original complaint. The [redacted] makes a determination to close or reopen the original complaint on the basis of the manufacturing site field service engineering investigation.

Complaint investigations associated with the following Complaint Investigation IDs received by Nellcor Ireland have been open since 2004 and were not closed at the time of the inspection:

  • Investigation ID [redacted], Creation Date: [redacted]

  • Investigation ID [redacted], Creation Date: [redacted]

  • Investigation ID [redacted], Creation Date: [redacted]

  • Investigation ID [redacted], Creation Date: [redacted]

  • Investigation ID [redacted], Creation Date: [redacted]

  • Investigation ID [redacted], Creation Date: [redacted]

5. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100.

For example, the [redacted] failures that occurred during the validation study conducted as a result of the transfer of the [redacted assembly and test process from [redacted] to Nellcor Ireland. Failure investigations were conducted to determine the root causes of the failures and corrective actions were identified . However, the preventive actions or the determination of whether preventive actions were necessary were not documented.

6. Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f).

For example, the functionality testing performed to qualify the [redacted] does not include a test protocol and acceptance criteria. Your firm conducts vertification testing of the [redacted] by comparing the [redacted] and [redacted] parts through functionality and assembly suitability testing and documenting these results on a Design Change Approval form [redacted]. However, there were no test protocols developed for this verification testing.

7. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements and to establish and maintain records of acceptable suppliers, as required by 21 CFR 820.50.

For example, your firm's purchasing control procedures, i.e. [redacted], and [redacted] do not specify Approve Manufacturer List (AML) vendors who supply subcomponents such as [redacted].

This letter is not intended to be an all-inclusive list of deficiencies 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 underlying 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.

We received responses from David Olson, Vice President Regulatory Affairs, dated March 24, 2005, May 3, 2005, and June 6, 2005, concerning our investigator's observations noted on the FDA 483. We have reviewed your response and have concluded that it is inadequate for the following reasons:

1. Your firm has revised the Product Design Change Approval procedure [redacted] to detail the requirements for design verification or validation testing. The revised procedure requires that an evaluation must be conducted on the design input and design output documents impacted by the proposed design change. Further, a risk analysis is required to identify risks associated with the proposed change, to determine the acceptable level of risks, and to provide traceability between design verification requirements and the need for design validation activities. Design validation is required when the risk analysis determines that there is an "impact". However, the level of "Impact" requiring design validation is not specified. Please specify the risk/hazard methods and procedures that will be used to define the level of "impact" requiring design validation. Further, please explain how the risk-analysis "impact" of this revised procedure will determine if design validation is necessary.

2. Please provide a summa including the results, of the Incoming Inspection Records for [redacted] that were reviewed to support your determination that the inspection results for [redacted], an [redacted] for the [redacted], which were not documented in accordance with the Incoming Inspection Procedure [redacted] was an isolated occurrence.

In addition, please provide a copy of the Non-Conforming Material Report (NCMR) for [redacted] and inspection record sheet [redacted] to verify the documentation of this part's inspection. Also, please highlight how the inspection record sheet of the originally inspected parts records how many parts were sampled, how many parts failed, what parts failed, and the reference to the applicable NCMR records.

3. Please provide a status of the following complaint investigations that were open since 2004 and were not closed at the time of our inspection [redacted]. In addition, please provide a progress update on your implementation of the revised Customer Complaint & Investigation procedure [redacted] including the number of open complaint investigations an failure investigation times.

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. 381(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 occurring 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, Orthopedics, Physical Medicine, and Anesthesiology Devices Branch (OPMAD), 2094 Gaither Road, Rockville, Maryland 20850 USA, to the attention of William MacFarland, Chief OPMAD.

If you need help in understanding the contents of this letter, please contact William MacFarland at the above address or at (240) 276-0120 or FAX (240) 276-0129.

Sincerely yours,


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