Inspections, Compliance, Enforcement, and Criminal Investigations
International BioResources, LLC 20-Jan-06
Department of Health and Human Services
Public Health Service
January 20, 2006
Ref to MIN-06-19
RETURN RECEIPT REQUESTED
Chief Executive Officer
International BioResources, LLC
1200 Camellia Boulevard, Suite 202
Lafayette, LA 70508
Dear Mr. Savoy:
On November 16-18, 21 and 28, 2005, the Food and Drug Administration (FDA) conducted an inspection of your facility located at 2530 W. North Avenue, Milwaukee, Wisconsin. Our investigators documented violations of section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2)(B)] and Title 21, Code of Federal Regulations. (21 CFR),Parts 600-680, as follows:
Many of the records intended to document the control of critical operations at your firm are not adequately maintained or reviewed as required. These records include, but are not limited to, deferred donor records and lot numbers of supplies used for specific units of.the final product 121 CFR 606.160(e) and 21 CFR 606.160(a)(2)]. Examples of the deviations include the following:
-There was no record for 25 deferred donors in your Permanent Medical Reject file 33 reviewed from your other area centers facsimile notifications; and
-There was no record of the lot numbers of sterile applicators used to prepare the phlebotomy site.
You failed to maintain written standard operating procedures (SOPs) including all steps to be followed in the collection and processing of blood and blood components for further manufacturing purposes .[21 CFR 606.100(b). Examples include the following:
- There is no SOP for handling the inter-center deferral lists to ensure deferred donors are added to your Permanent Medical Reject file;
- The SOP for quality control checks to ensure donor index card files remain in alphabetical order does not specify when checks will be
performed or how the checks will be documented;
- There is no SOP for -handling -temporarily deferred donors when notified of these by area centers;
- Deferred donors from other centers are not entered into your deferred donor index card files within one working day as stated in your SOP (Permanent Donor Index Card File System, Document Number: 212; page 8);
- Two person verifications are not being performed on all temporary and permanently deferred donor index cards created as stated in your SOP (Permanent Donor Index Card File System, Document Number 2.12, page 9);
- All donor cards are not being filed' alphabetically and being verified for accuracy and correct alphabetization to ensure unsuitable donors are not allowed to donate as stated in your SOP (Permanent Donor Index Card File System, Document Number 2.12, page 1);
- Outgoing inter-center deferral fists (Form WIM021C) are not being faxed to all area plasrnapheresis centers at the close of business each day as stated in your SOP (Cross-Donation Prevention Procedure, Document Number WIM 021);
- Donor Center Notifications (Document Number: 6.2B) identifying donors with positive viral markers are not being sent out within one working day of notification from the lab as required in your Unsuitable Product Checklist SOP (Document Number: 6.2.I, page 3);
- An unsuitable Product Disposition Record (UPDR) was not created for an unsuitable unit of plasma (#178003231) collected from a PMR donor [redacted] as required by your Disposition of Unsuitable Product and Red Blood Cells SOP, Document Number: 6.4.
Discrepancies in records are not investigated and followed up adequately [21 CFR 606.100(c)]. Examples include the following:
- Your Internal Investigation Report (IIR) number 05-11-023 recording missing Inter-Center Deferral Lists was closed without attempting to recreate and ensure distribution to the area Centers.
- Your IIR number OS-10-001 report of your investigation of out-of-limit hemostat controls does not include a determination. of whether the out-of- limit ranges may have affected donors with a borderline hematacrit or training for the employees involved:
The above identified deviations are not intended to be an all-inclusive list of deficiencies at your Milwaukee,' Wisconsin', facility. It remains your responsibility to ensure that your establishment is in compliance with all requirements of the federal regulations.
We are in receipt of the letter dated December 7, 2005, from Michael Messick, VP, Regulatory Affairs/Quality Assurance and Authorized Official/FDA. This correspondence responds to the Form FDA-483 issued to Cari Martin, Center Manager of the Milwaukee facility, at the conclusion of the inspection. We have reviewed the corrective actions described in the response and have determined that the response is inadequate to address our concerns. The response fails to demonstrate to us your recognition of the seriousness of your quality controsystem failures. For example, your firm has reassigned employee duties and revised SOPs but the response does not address training employees to follow SOPs in general. Only a future re-inspection can evaluate the adequacy and permanence .of your stated changes and corrections. If you care to respond further to these matters, please do so to the attention of Judy E. Heisick, Compliance ,Officer at the address in the letterhead. Failure to promptly and effectively correct these deviations may result in initiation of regulatory action without further notice. Such action includes license suspension and/or revocation, seizure and/or injunction.
W. Charles Becoat