Respironics Inc. announces receipt of warning letter from United States Food and Drug Administration.

MURRYSVILLE, Pa.--(BUSINESS WIRE)--Dec. 30, 1994--Respironics Inc. (NASDAQ/NMS:RESP) announced Friday that it received a warning letter from the United States Food and Drug Administration (FDA) as a result of an audit conducted by FDA investigators earlier in the year.

As previously disclosed by the company, two FDA audits were conducted at the company's facilities during the fiscal year ended June 30, 1994. The warning letter received relates to the second of these audits conducted from May 1994 through August 1994.

In the letter, the FDA raises several issues related to the company's complaint handling and reporting processes and claims that certain modifications to the company's BiPAP non-continuous ventilator systems were not reviewed by the FDA under the FDA's 510(k) notification and review process.

Requested company responses include refinements to systems and processes as well as filing additional reports and additional 510(k) documents for certain device improvements and claims.

"Management is currently reviewing the letter and has requested a meeting with FDA officials," stated Dennis S. Meteny, president and chief executive officer. "It is our intent to cooperate fully with the agency to bring prompt and positive resolution to all issues raised in the letter and eliminate any regulatory uncertainty associated with these latest findings.

"We do not anticipate any interruption in our business and strongly believe we are in substantial compliance with the FDA's requirements." Meteny added, "We remain committed to meeting the challenge of the current regulatory environment through compliance with both our own internal quality standards and regulations established by agencies such as the FDA."

Respironics was recently awarded the American Association for Respiratory Care's annual Zenith Award for quality of products and service. The 1994 award is the company's second in succession and the third in the past four years. Respironics was one of five firms selected from the 358 eligible for the award in 1994.

Respironics Inc. designs, manufactures and markets respiratory products for use in home, hospital and emergency care situations.

CONTACT: Respironics Inc., Murrysville

              Dorita A. Pishko, Investor Relations, 412/733-0209 or
              Daniel J. Bevevino, Controller & CFO, 412/733-0235