Inspections, Compliance, Enforcement, and Criminal Investigations
Steridyne Industries LLC 17-Aug-04
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
August 17, 2004
President and Owner
Steridyne Industries, LLC
3725 Investment Lane
Riviera Beach, Florida 33404-1730
Dear Mr. Howson:
During an inspection of your establishment located at 3725 investment Lane, Riviera Beach, Florida, on April 15,, 2004, the FDA Investigator determined that your firm is a manufacturer of plastic covers (sheaths) for thermometers and curing lights and a repacker and distributor of thermometers, probes, monitors, and curing light sleeves. These products are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above-stated inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System (QS) regulation as specified in Title 21, Code of Federal Regulations (CFR), part 820. Significant deviations include, but are not limited to, the following:
1. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives as required by 21 CFR 820.20(c). Your firm failed to conduct any management reviews (FDA 483; Item #1).
2. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited as required by 21 CFR 820.22. The Operations Manager responsible for all manufacturing operations conducted the quality audits (FDA 483; Item #2).
3. Each manufacturer shall establish quality system procedures and instructions as required by 21 CFR 820.20(e). Your firm failed to follow established procedures for the Device History Record (DHR); Acceptance Activities; Control of Nonconforming Product; Labeling and Packaging Control; and Purchasing by not maintaining written documentation for established procedures approved in 1997 after the previous GMP inspection (FDA 483; Item #3).
4. Each manufacturer shall document all activities related to changes to a specification, method, process or procedure as required by 21 CFR 820.70(b). Your firm discontinued sterilization of plastic covers without any consideration for the labeling of the [redacted] crystal temperature monitors, and [redacted] curing light tips, which continue to bear statements that state at the plastic covers are sterile. This change was not documented (FDA 483; Item #4).
5. Each manufacturer shall maintain device history records (DHRs) to ensure that each batch or lot demonstrates that the device is manufactured in accordance with the device master record (DMR) as required by 21 CFR 820.184. Your firm lacked device history records for the manufacturing of thermometer covers (FDA 483; Item 5).
6. Each manufacturer shall control labeling and packaging operations. The label and labeling used for each product lot or batch must be documented in the DHR as required by 21 CFR 820.120(d). Your firm lacked documentation for labels/labeling used for each lot or batch of thermometer covers manufactured (FDA 483; Item #6).
7. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all QS activities are correctly performed as required by 21 CFR 820.25. Your manufacturing employees have-not received any training related to the QS regulation since 1997 (FDA 483; Item #7).
The above-stated inspection also revealed that the plastic covers (sheaths) intended for use with thermometers, monitors, probes, and curing lights are misbranded within the meaning of section 502(a) of the Act in that the labeling for [redacted] Thermometer covers [redacted] and [redacted] Liquid Crystal Temperature Monitors; [redacted] and declare "Sterile", "Instant Sterilization", "Sterile for O.R. use", "with Sterile 70mm [redacted] Probe Covers", and "Infection Control Barrier for Curing Light Tips." These statements are, false or misleading because the thermometer covers are not sterile.
Your thermometer for use in the O.R., sheath for the electronic thermometer, and sheaths for cure lights are adulterated under section 501(f)(1)(B), in that they are class III devices under section 513(f) of the Act and do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) or approved applications for an investigational device exemption under section 520(g).
These devices are misbranded under section 502(0) of the Act, in that notices or other information respecting the thermometer for use in the O.R., sheath for the electronic thermometer, and sheaths for cure lights were not provided to the FDA as required by section 510(k). The kind of information you need to submit in order to obtain marketing clearance is available through the internet at http://www.fda.gov/cdrh/devadvice. FDA will evaluate this information and decide whether your products may be legally marketed.
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 regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the 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 applications for premarket approval of Class III-,devices to which the Quality Systems regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence or similar 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 Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Director, Florida District