Inspections, Compliance, Enforcement, and Criminal Investigations
Spectronics Corporation 19-May-05
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REOUESTED
May 19, 2005
Bernard William Cooper
Chief Executive Officer
956 Brush Hollow Road
Westbury, NY 11590-1731
Dear Mr. Cooper:
During an inspection of your establishment located in Westbury, NY on April 5, 6, and 12, 2005, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures x-ray autoradiography cassettes. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C.321(h).
The above-stated inspection revealed that these devices are 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 conformance with the Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, and the medical device reporting requirements of 21 CFR Part 803.
The deficiencies include the following:
1. Failure to prepare and maintain an approved device master record for your x-ray autoradiography cassettes that includes or refers to the location of device specifications;production process specifications; quality assurance procedures and specifications; packaging and labeling specifications; and installation, maintenance, and servicing procedures, as required by 21 CFR 820.181 and 820.40.
2. Failure to develop, maintain, and implement Medical Device Reporting procedures for reporting deaths and serious injuries to which a device has or may have caused or contributed, as required by 21 CFR 803.17 and 803.3(r).
3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
4. Failure to document the evaluation and selection of potential suppliers for their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). For example, there was no documented evaluation of the current supplier of lead sheets used in the manufacture of your x-ray autoradiography cassettes.
This letter is not intended to be an all-inclusive list of deficiencies at your firm. It is your responsibility to ensure adherence to each requirement of the Act and its implementing regulations. The specific violations noted in this letter and in the Form FDA 483 (copy enclosed) issued to and discussed with John T. Duerr, Vice President of Operations, at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm's quality system. You are responsible for investigating and determining the causes of the violations identified by FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submissions for Class III devices to which the Quality System/Good Manufacturing Practice deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Bruce A. Goldwitz, Compliance Officer, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Tel. (718) 340-7000 ext. 5582.
Jerome G. Woyshner