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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Russell C. Davis Planetarium 10/27/10

  

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

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

OCT 27 2010


via UNITED PARCEL SERVICE
WARNING LETTER
NOTIFICATION OF NONCOMPLIANCE


Ms. LaNeysa Harris
Assistant Manager
Russell C. Davis Planetarium
201 E. Pascagoula Street
P.O. Box 17
Jackson, Mississippi 39201-4101


Ref:OCER: COR10000407-000


Dear Ms. Harris:


This letter is written to advise you of items of noncompliance with the laser product performance standard and regulations encountered during an inspection of your laser light show operations by Mr. Leo J. Lagrotte, Electro Optics Specialist of the Food and Drug Administration Southeast Region on June 15, 2010.


1. 21 CFR 1040.11(c) and 1010.4. Your laser light shows exceed the accessible emission limits of Classes I, IIa, II, and IIIa and your firm failed to apply for a renewal or reinstatement of the variance, Docket No. (b)(4), which you had been granted and expired on 2/16/2003.


The following failures ·to comply with the regulations covering records and reports were observed:


2. 21 CFR 1002.30(a) (1). Your firm failed to implement the requirements to complete and retain for five years your Laser Presentation Evaluation forms to record compliance with the radiation safety requirements before each show.


3. 21 CFR 1002.13. Your firm failed to file annual reports with FDA, as required, by September 1 of each year since your last annual report on 8/15/2002, Accession No. (b)(4)


Section 538(a) of the Act, 21 U.S.C. 360oo(a), prohibits any manufacturer from certifying or introducing into commerce electronic products which do not comply with an applicable standard. This section also prohibits any manufacturer from failing or refusing to establish and maintain required records or to submit required reports. Failure to respond to this letter may be considered to be a violation of section 538(a) (4) of the Act, 21 U.S.C. 360oo(a) (4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp. Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA. In cases where a foreign manufacturer fails to respond, penalties may be imposed upon importers.


You are not being requested to submit a formal corrective action plan at this time, however, all of your equipment and future performances must comply with the Federal performance standard/variance. Persons failing to correct violations may be subject to regulatory action. If you feel that the alleged failures to comply do not exist, you may present your views and evidence within 15 working days of receipt of this letter.


You must respond to each of the items listed above stating what actions you will take and what changes you will make to your equipment or shows to achieve full compliance. Your response should be submitted as a supplement to your report within 15 working days of receipt of this letter, clearly referencing the appropriate accession number.


Your response should be sent to: Chief, Electronic Products Branch, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health, 10903 New Hampshire Ave., WO66-4621, Silver Spring, Maryland 20993-0002. You are also requested to send a copy of your response to: Director, Compliance Branch, Florida District Office, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have further questions regarding these requirements, please contact Dale Smith, Consumer Safety Officer, of the Electronic Products Branch at (301) 796-5710.


Sincerely yours,
/S/

Lynne L. Rice
Director
Office of Communication, Education,
and Radiation Programs
Center for Devices and
Radiological Health