Inspections, Compliance, Enforcement, and Criminal Investigations
HemaCare Corporation 27-Apr-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REOUESTED
April 27, 2006
CEO & President
21101 Oxnard St
Woodland Hills, CA 91367-5013
Dear Ms Irving:
During an inspection of HemaCare Corporation, 21101 Oxnard St, Woodland Hills, and 4954 Van Nuys Blvd., Sherman Oaks, CA our investigators documented deviations from Section 502(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 352(a)(2)(B)] and Title 21, Code of Federal Regulations (CFR) Parts 600-680 as follows:
Failure to notify consignees of blood components made from prior collections within 72 hours from a donor who subsequently tested HIV positive [21 CFR 610.46(a)(1)]. Specifically, you did not notify consignees of prior units from the donor of unit [redacted] collected 3/22/2005.
Failure to notify a donor that the donor is deferred and the reason for deferral [21 CFR 630.6 (b)(1)]. Specifically, the donor of unit [redacted] was not notified of positive HIV test results.
Failure to maintain concurrent documentation of each significant step in the collection [21 CFR 606.160 (a)(1)]. Specifically, the phlebotomist did not record whether or not the donor for unit [redacted] had a reaction.
Failure to have written and approved procedures in place [21 CFR 606.100(b)]. Specifically, there is no written and approved procedure describing a standard method of entering donor demographics into your databases and/or describing what routine reports are to be run and how to review the reports for maintaining the Tracking Card Database.
Failure to maintain written standard operating procedures for all steps in the collection, processing, storage and distribution of blood and blood components as follows [21 CFR 606.100(b)].
SOP HS-COL-495 does not include all significant steps used to check for deferred donors in that hyphenated names, special characters, former names, different spellings and use of all search pathways are not addressed.
SOP RS-002 does not include all significant steps associated with use of the Tracking Card Database in that hyphenated names and special characters are not addressed.
Failure to follow written standard operating procedures for all steps in the collection, processing, storage and distribution of blood and blood components as follows [21 CFR 606.100(b)].
The unit numbers on satellite bags were not being compared with the unit numbers on the primary whole blood bag as required by procedure SO-LAB-561.
At least 4 donors were not deferred as required by SOP-102.
An occurrence management report was not generated when a duplicate plateletpheresis donor chart was created as required by SOP-011
Failure to perform a thorough investigation of an unexplained discrepancy [21 CFR 606.100(c)].Specifically, corrective action for 1 of 21 BPD's was incomplete.
The above identified deviations are not intended to be an all inclusive list of deficiencies at your facilities. It is your responsibility to assure that your establishment is in complete compliance with all requirements of the federal regulations.
You should take prompt measure to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such action includes license suspension and/or revocation, seizure, and/or injunction.
Please notify this office in writing, within 15 working days of receipt of this letter of steps you have taken to correct the noted violations and to prevent their recurrence. 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. If you have any questions concerning this letter, you may contact Barbara Rincon, Compliance Officer at telephone number (949) 608-4439.
Your reply should be sent to:
Pamela B. Schweikert
Director, Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92612
Alonza E. Cruse