Inspections, Compliance, Enforcement, and Criminal Investigations
Haemacure Corporation 05-Jan-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
January 5, 2006
Marc Paquin, President & CEO
2 North Tamiami Trail
Sarasota, FL 34236-5585
Dear Mr. Paquin:
During an inspection of your establishment located in Sarasota, Florida on November 28-29, 2005, our investigator determined that your establishment is a manufacturer and distributor of the HemaMyst Piston Syringe, HemaSyst and accessories (Class II). These 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 investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), part 820. These violations cause the device(s) you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. § 351(h)] of the Act.
The Act requires that manufacturers conform to the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
Quality System Requlation
The investigator noted the following violations of the QS regulation:
1. Your firm failed to ensure that quality system requirements are effectively established and maintained and that procedures for management review have been established as required by 21 CFR 820.20(b)(3)(i) and (c). Your quality manual was not implemented until November 11, 2005 and specifications for devices, critical components and materials have not been adequately verified or tested after receipt from the supplier or the contract manufacturer. Furthermore, procedures were not established to ensure that the quality system was established and implemented and functioned as designed (FDA 483, Items #1 & 2).
2. Your firm has never conducted a quality audit pursuant to your written procedures to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22 (FDA 483, Item #3).
3. Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. 21 CFR 820 .75(a). Your firm failed to fully ensure that sterile products are properly validated. Sterilization of your products was switched from one vendor to another without your knowledge and the validation reports relied upon by the current sterilizer were not your products and/or similar type. Process validation has not been conducted nor documented (FDA 483, Items #10 & 11).
4. Your firm failed to evaluate and select potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including quality, manufacturing, sterilization and packaging requirements and document these activities as required by 21 CFR 820.50(a)(1). Your firm has no approved vendor agreements with your contract suppliers, vendors and manufacturers to ensure that specified requirements are met through scheduled audits (FDA 483, Item #13).
5. Your firm failed to establish and implement complaint handling procedures as required by 21 CFR 820.198(a). Your Complaint Report form fails to include the need for review and/or investigation, who would conduct the investigation, their conclusions and any response back to the complainant (FDA 483, Item #8).
6. Your firm failed to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b). Such changes shall be verified or where appropriate validated according to §820.75. Your contract manufacturer changed sterilizers and there was a failure to ensure that appropriate sterilization validation was conducted and properly documented (FDA 483, Item #6).
7. Your firm failed to document acceptance activities required by 21 CFR 820 .80 including records to show the following pursuant to 21 CFR 820.80(e): (1) acceptance activities are performed, (2) the dates acceptance activities are performed, (3) the results; (4) the signature of individual(s) conducting the acceptance activities; and (5) where appropriate the equipment used. Your firm received the plastic spray head component for the HemaMyst device directly from the foreign component manufacturer without verifying whether the component met specifications or other quality requirements . No incoming inspection procedures have been established and conducted (FDA 483, Item #7).
8. Your firm failed to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria as required by 21 CFR 820.80(d). Your firm has not established finished device acceptance procedures and finished devices were released without proper authority (FDA 483, Item #9).
9. Your firm failed to designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements required by 21 CFR 820.40(a). Your firm's SOP AQ10.01 E - SOP System requires annual review of all SOPs; however, the procedure has never been implemented and the reviews have never been conducted. The investigator also observed SOPs that were not signed by a designated individual (FDA 483, Items #12 & 14).
10. Your firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met and a design history file (DHF) has not been established and maintained as required by 21 CFR 820.30(a) & (j). Your firm has no procedures to address design and design changes and there is no system in place to document design activities (FDA 483, Items #4 &5).
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. 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.
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 penalties. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
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 (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) 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.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, telephone number (407) 475-4728.
Director, Florida District