Inspections, Compliance, Enforcement, and Criminal Investigations
New Life Generation, Inc. 10/17/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
October 17, 2011
Duane E. DuCharme,
Chief Executive Officer
New Life Generation, Inc.
9755 Westpoint Drive
Indianapolis, Indiana, 46256-3396
Dear Mr. DuCharme:
The Food and Drug Administration (FDA) conducted an inspection of your firm, New Life Generation, Inc., 9755 Westpoint Drive, Indianapolis, Indiana from July 19, 2011 through August 10, 2011. During this inspection, the FDA investigators documented significant deviations from the regulations for human cells, tissues, and cellular and tissue - based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, Part 1271 (21 CFR 1271 ), and issued under the authority of Section 361 of the Public Health Service Act (42 USC 264).
The deviations documented on the Form FDA 483 were presented to, and discussed with, you at the conclusion of the inspection. The items of concern include, but are not limited to, the following:
1. Failure to maintain records concurrently with the performance of each step required in subpart C and subpart D of Part 1271 [21 CFR 1271.270(a)]. Any requirement in Part 1271 that an action be documented involves the creation of a record. All records must be accurate, indelible, and legible. The records must identify the person performing the work and the dates of the various entries, and must be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular HCT/P involved. For example:
a. During the inspection, our investigators found discrepancies between the documentation of responses on the Medical Social History Interview form (Scr. Form #27 5/04/11) and the recorded next of kin (NOK) medical social history interviews. Two screeners either omitted questions or did not ask the entire question relating to behaviors associated with risk factors for relevant communicable disease agents and diseases; however responses were documented on the Scr. Form #27 5/04/11 as if the questions were asked. Examples include:
1. The NOK for donor (b)(6) reported that the donor had sexual contact, within the six months prior to death, with an individual known to have hepatitis. The screener documented a "No" answer to the question relating to this behavior. In addition, several questions regarding risk factors for hepatitis or human immunodeficiency virus (HIV) were not asked in their entirety.
2. During the interview with the NOK for donor (b)(6) the screener did not ask several questions regarding risk factors for hepatitis, HIV, and variant Creutzfeldt-Jakob disease (CJD) in their entirety.
3. During the interview with the NOK for donor (b)(6) the screener omitted several questions regarding risk factors for hepatitis and HIV.
4. During the interview with the NOK for donor (b)(6) the screener omitted several questions regarding risk factor for hepatitis, HIV, and variant CJD.
b. The Medical Social History Interview form (Scr. Form #27 9/18/09) contained changes to the original responses from the NOK for questions related to risk factors for relevant communicable disease agents and diseases and were made without indicating the source of the new information. For example:
1. The Medical Social History Interview form for donor (b)(6) was completed by screener (b)(6) on November 22, 2010. regarding a history of eye diseases and infections for eye donors was marked "NA." On December 7, 2010, the record was changed such that "NA" was crossed out and the "No" box was checked. The changes were initialed and dated by (b)(6) and (b)(6) However, there is no documentation in the donor record to indicate the source of the new information.
2. The Medical Social History Interview form for donor (b)(6) was completed by screener (b)(6) on January 28, 2011. Question #21, regarding a history of neurological or brain disease, and question #21a, regarding a familial history of CJD, had multiple changes to the "Yes" and "No" answers. Responses were documented during the initial NOK interview on January 28, 2011 and changes were made by (b)(6) and (b)(6) on March 8, 2011 and March 17, 2011. There is no documentation in the donor record to indicate the source of the new information.
2. Failure to screen a donor of cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. Relevant medical records means a collection of documents that includes a current donor medical history interview; a current report of the physical assessment of a cadaveric donor or the physical examination of a living donor; and if available, laboratory test results, medical records, coroner and autopsy reports, and records or other information received from any source pertaining to risk factors for relevant communicable diseases, as defined in 21 CFR 1271.3(s). Medical records, which were available, were not obtained and reviewed as part of donor screening and donor eligibility determination. For example:
a. The medical history interview record for donor (b)(6) indicate that the donor had a recent history of drug and alcohol use and had methadone in (b)(6) system at the time of death. The names of two primary care physicians were also documented in the donor's record, however the physicians were not contacted to request the donor's records, although FDA investigators readily obtained the records during the inspection. The donor was determined eligible on December 27, 2010. Your firm distributed skin from this donor and sent musculoskeletal and connective tissues to a processor on January 4, 2011.
b. Records for donor (b)(6) indicate that the donor died at a hospital, however the hospital records, which were available, were not obtained prior to making the donor eligibility determination. The Plasma Dilution Record (Rec. Form #13 09/18/09), included in the recovery records, documents the "Plasma Dilution Determination" as "N/ A" and "No" to the question, "Did the donor receive any infusions or transfusion?" During the inspection, FDA investigators obtained the hospital records for donor (b)(6) and found that the donor was hospitalized for three days prior to received intravenous fluids during the entire hospital stay. Based on this information, the donor was not properly evaluated for plasma dilution, despite the fact that the donor received infusions prior to death and the specimen for relevant communicable disease testing was collected post-mortem. The donor was determined eligible without a review of all available relevant medical records.
3. Failure to establish and maintain a method for documenting the disposition of each of your HCT/Ps, to enable tracking from the donor to the consignee or final disposition [21 CFR 1271.290(e)]. For example, a review of your list of HCT/Ps recovered by donor, as well as your quarantined inventory log and shipping records found the following discrepancies:
a. Skin grafts (b)(6) and (b)(6) recovered from donor (b)(6) were not on the list of distributed HCT/Ps or on the quarantine log. There was no documentation of the dispositions of these HCT/Ps.
b. (b)(6) skin grafts, recovered from donor (b)(6) were not on the list of distributed HCT/Ps or on the quarantine log. There was no documentation of the dispositions of these HCT/Ps.
c. Skin graft (b)(6) recovered from donor (b)(6) was not on the list of distributed HCT/Ps or on the quarantine log. There was no documentation of the disposition of this HCT/P.
4. Failure to establish and maintain a quality program intended to prevent the introduction, transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps [21 CFR 1271.160]. For example, your quality program failed to ensure that personnel were trained to perform their assigned functions related to donor screening requirements. During the medical history interviews with NOK, your screeners were not asking all required questions about a donor's medical history and relevant social behavior in regard to relevant communicable disease risk. One of these screeners has been performing medical history interviews since December 3, 2009 and the other since August 21, 2010.
The above identified violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all applicable requirements of federal regulations. You are responsible for reviewing your operations as a whole to assure you are in compliance with all of the FDA regulatory requirements. You should take prompt action without further notice. Failure to do so may result in additional regulatory action. Such action may include, but is not limited to, an order to retain, recall, destroy, or cease manufacturing of HCT/Ps.
We acknowledge receipt of your letter dated August 30, 2011 that provides a response to FDA's inspectional observations. We understand that your corrective actions are still ongoing and thus will be reviewed during the next inspection of your firm. Please provide the results of your Donor Medical Social History re-interviews with the NOK, as well as your retrospective review of donor records to ensure adequate information and available records were obtained for donor eligibility determinations.
You should respond in writing within fifteen (15) working days of receipt of this letter, with the specific steps you have taken to correct the noted deviations, including an explanation of each step being taken to prevent the recurrence of similar deviations. If corrective action cannot be completed within fifteen (15) working days, please state the reason for the delay and the time frame within which the corrections will be completed.
Please send your written reply to the Food and Drug Administration, Attention: Catherine V. Quinlan, Compliance Officer, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions regarding any issues in this letter, please contact Ms. Quinlan at (313)393-8153.
Glenn T. Bass
Detroit District Office