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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Philips Lighting B.V. 16-Jul-04

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

Public Health Service
Food and Drug Administration


2098 Gaither Road
Rockville MD 20850


JUL 16 2004


Mr. Paul J. van den Kerkhoff
Business Line Manager
Philips Lighting B.V.
P.O. Box 1109
4700 BC Roosendaal, The Netherlands

Dear Mr. van den Kerkhoff:

During an inspection of your firm located in Roosendaal, The Netherlands on March 1-4, 2004, our investigators determined that your firm manufactures Class II lamps (Ultraviolet Dermatological Lights) used for Phototherapy (psoriasis, vitiligo, hyperbitirubinemia, and vitamin D3-photosynthesis). 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 implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your Quality System procedure manual does not include requirements for: analyzing sources of quality data to identify existing and potential causes of nonconforming product or other quality problems; verifying or validating corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device; and submitting relevant information related to identified quality problems, as well as corrective and preventive actions, for management review. In addition, your CAPA procedures do not include requirements for ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.

2. Failure of design verification to confirm that the design output met the design input requirements, as required by 21 CFR 820.30(f). For example, not all of the design inputs were met/tested for the

a. According to the input requirements, lamps were required to be tested at [redacted] hours for color testing. Actual testing was only done at [redacted]

b. One of the design inputs for ultraviolet (UV) radiation at [redacted] was [redacted]. The actual measurement was [redacted] with no documentation of this deviation or rationale for acceptance.

3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, which ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a)(3). For example, 7 out of 7 complaints reviewed for "Type 01 Medical Bulbs" did not have a MDR evaluation.

4. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, you do not have written procedures or conduct incoming testing for acceptance of raw materials used to manufacture Class 11 lamps (Ultraviolet Dermatological Lights).

5. Failure to maintain procedures to ensure that the Device History Records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. For example, out of 17 DHR's reviewed, 5 (29%) were incomplete. Specifically,

- 4 records had out of specifications test results that were not addressed.
- 1 record had a faulty measurement that was not addressed.

We also note that you failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.

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 quality system. 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 Mr. Paul J. van den Kerkhoff, Business Line Manager UV, dated April 6, 2004; and Mr. James R. Cyre, PLCNA Regulatory Administrator, dated April 7, 2004, concerning our investigators observations noted on the FDA 483. We have reviewed both letters but we are unable to determine whether your responses are adequate because you did not provide sufficient documentation of your corrective actions.

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. 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 A, General Surgery Devices Branch, 2098 Gaither Road, Rockville, Maryland 20850 USA, to the attention of Wayne Q. Miller.

If you need help in understanding the contents of this letter lease contact Mr. Miller at the above address or at (301) 594-4618 or FAX(301) 594-4636.

Sincerely yours,


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

cc: James R. Cyre
PLCNA Regulatory Administrator
Philips Liithting Company
3861 S. 9 Street
Salina, KS 67401