FDA WARNING_LETTER - Russell C. Davis Planetarium - June 15, 2010

The FDA issued a Warning Letter to Ms. LaNeysa Harris, Assistant Manager of Russell C. Davis Planetarium, following an inspection on June 15, 2010, which identified non-compliance with laser product performance standards and regulations. The inspection revealed three primary violations: 1) The planetarium's laser light shows exceeded accessible emission limits for Classes I, IIa, II, and IIIa, and the firm failed to renew or reinstate a variance that expired in 2003, as required by 21 CFR 1040.11(c) and 1010.4. 2) The firm failed to implement and retain Laser Presentation Evaluation forms for five years to document compliance with radiation safety requirements before each show, violating 21 CFR 1002.30(a)(1). 3) The firm failed to file annual reports with the FDA by September 1 each year since its last report in 2002, a violation of 21 CFR 1002.13. The letter emphasizes that Section 538(a) of the Act prohibits manufacturing or introducing non-compliant electronic products into commerce and failing to maintain records or submit reports. Failure to respond or correct these violations may lead to regulatory actions, including injunctions and civil penalties of up to $1,100 per violation, with a maximum of $355,000. While a formal corrective action plan is not immediately requested, all equipment and future performances must comply with federal standards. The firm must respond within 15 working days, detailing actions to achieve full compliance.