Inspections, Compliance, Enforcement, and Criminal Investigations
Southern Tier Plastics Inc 20-Mar-06
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
March 20, 2006
Joyce A. Gray
Southern Tier Plastics, Inc.
94 Industrial Park Drive
Binghamton, NY 13902
Dear Ms. Gray:
During an inspection of your establishment located in Binghamton, New York on February 13 through 17, 2006, our investigator determined that your establishment manufactures respiratory gas humidifiers and tracheal tube holders, which are devices as defined by Section 201(h) [21U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act).
The above stated inspection also revealed that these devices are adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] of the Act, in that the methods used in, or facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation for medical devices, as specified in Title 21 CFR, Part 820, as follows:
1. Failure to conduct quality audits to verify that quality system requirements are effective and being fulfilled [21 CFR 820.22].
2. Failure to document approval of documents to assure review for adequacy prior to issuance [21 CFR 820.40(a)]. For example, the set up procedures for press operators, control inspection instructions, and changes to standard operating procedures are not signed by the preparer or approving official.
3. Failure to fully document acceptance activities [21CFR 820.80(e)]. For example, quality control records do not include the signature of the individual(s) conducting the acceptance activities.
4. Failure to ensure that all employees receive adequate documented training [21 CFR 820.25(b)].
5. Failure to document the appointment of a manager with authority and responsibility for ensuring that the quality system requirements are effective and reporting performance of the quality system to executive management [21 CFR 820.20(b)(3)].
6. Failure to use a calibration standard for test equipment which is traceable to national or international standards [21 CFR 820.72(b) (1)]. For example, the pressure gauge on the test equipment for the humidifier canister is not traceable to a national or international standard, nor is it an independent reproducible standard.
7. Failure to include in Device History Records the labeling used for each production unit [21 CFR 820.184(e)].
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and FDA regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's quality system. You should note that several of these violations were previously brought to your attention after an inspection of your firm in 2003. You are responsible for investigating and determining the causes of the violations identified by the FDA. You must also 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. Also no requests for Certificates to Foreign Governments will be approved until the violations related to the subject device 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 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. 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 Laurence D. Daurio, Compliance Officer, at the above address.
Joseph F. McGinnis
Acting District Director