From: Subject: Rosenthal Eye and Facial Plastic Surgery Warning Letter Date: Wed, 24 Dec 2008 10:42:49 -0500 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C965B4.5DD468D0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C965B4.5DD468D0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/archive/g5276d.htm Rosenthal Eye and Facial Plastic Surgery Warning = Letter
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Department of Health and Human = Services

Public Health Service
Food and Drug = Administration

 


Center for Devices and Radiological Health
2098 Gaither=20 Road
Rockville, MD 20850



Via Federal Express

APP 11 2005

WARNING LETTER

Kenneth J . Rosenthal, MD
Rosenthal Eye and Facial Plastic = Surgery
310=20 East Shore Road, Suite 102
Great Neck, NY 10023

Dear Dr. Rosenthal:

The purpose of this Warning Letter is to = inform=20 you of objectionable conditions found during a recent Food and Drug=20 Administration (FDA) inspection at your firm. This letter also requests = that=20 prompt corrective actions be implemented in response to the violations = cited.=20 The inspection took place during the period from December 29, 2004 = through=20 January 19, 2005, and was conducted by Mr. Robert C. Steyert, an = investigator=20 with FDA's New York District Office. We also wish to acknowledge receipt = of your=20 letter to Mr. Jerome Woyshner, District Director of the FDA New York = District=20 Office, dated January 28, 2005, in which you responded to the = inspectional=20 observations .

The purpose of the inspection was to determine if your activities as = a=20 Clinical Investigator (CI) of human research studies complied with = applicable=20 FDA regulations, published in Title 21, Code of Federal Regulations, = Part=20 50-Protection of Human Subjects, and Part 812-Investigational Device = Exemptions=20 [21 CFR 50 and 812] . The two clinical trials that were the subjects of = the=20 inspection were the subjects of the inspection were: [redacted],=20 [redacted], [redacted], [redacted],[redacted],=20 [redacted], [redacted], [redacted], [redacted], [redacted], = sponsored=20 by [redacted] [redacted], Inc. (IDE # [redacted] = and=20 [redacted], [redacted], [redacted], [redacted],=20 sponsored [redacted], [redacted], [redacted] = Inc. (IDE=20 # [redacted]. The products used in the studies are devices as = that term=20 is defined in Section 201(h) of the Federal Food, Drug and Cosmetic Act = [21=20 U.S.C. 321(h)] (the FDC Act).

The inspection was conducted under a program designed to ensure that = data and=20 information contained in applications for Investigational Device = Exemption=20 (IDE), Premarket Approval (PMA), Product Development Protocol (PDP), or=20 Premarket Notification [510(k)] submissions are scientifically valid and = accurate. Another objective of the program is to ensure that human = subjects are=20 protected from undue hazard or risk during the course of the scientific=20 investigation.

Our review of the inspection report prepared by the New York District = Office=20 revealed violations of Title 21, Code of Federal Regulations (21 CFR), = Part 812=20 - Investigational Device Exemptions. FDA Investigator Steyert listed his = findings on a Form FDA-483, "Inspectional Observations," and discussed = these=20 findings with you at the conclusion of the inspection.

The deviations noted on the FDA-483, your written responses to those=20 deviations, and issues from our subsequent review of the inspection = report are=20 discussed below .

1. Failure to maintain accurate, complete, and current records = relating to=20 your participation in an investigation [21 CFR 812.140(a)] .

Responsibilities of clinical investigators include maintaining = accurate,=20 complete, and current records relating to the investigator's = participation in an=20 investigation .

You failed to adhere to the above stated regulation. Examples of this = failure=20 include but are not limited to the following:

a. You failed to maintain complete records regarding the receipt, = use, or=20 disposition of a study device [21 CFR 812.140(a)(2)(iii)). For example, = during=20 the inspection, you provided information to Mr. Steyert that indicated = you=20 received [redacted] study devices for the [redacted] study = on=20 8/12/02 . You subsequently enrolled [redacted] subjects into the=20 study.

However, you provided no records to document the specific devices = that were=20 returned to the sponsor or otherwise disposed.

This was a repeat violation from an inspection that was conducted = in=20 October 2001, for which you subsequently received an Untitled Letter = from FDA on=20 December 12, 2001.

Your written response to this observation is inadequate. You stated = that=20 documentation of test article accountability "was always maintained in = the=20 Operating Room Notebook and was available. We do acknowledge that during = the=20 exit interview we were unable to immediately remember its location in = the study=20 records." A Clinical Investigator's obligations include maintenance of = complete=20 records regarding the disposition of every device provided to you as = part of a=20 clinical trial . Furthermore, the FDC Act requires that you permit a = reviewing=20 FDA official access to records related to IDE studies [FDC Act =A7 = 704(e)] . The=20 device accountability records were not provided to Mr. Steyert during = the=20 inspection nor did they accompany your response. If you have now located = these=20 records, please forward them to us with your response to this = letter.

b. You failed to maintain accurate and complete records for each = subject's=20 case history and exposure to the device [21 CFR 812.140(a)(3)]. The = study=20 subjects' records contained numerous inaccuracies and inconsistencies . = For=20 example:

i . [redacted] Study Patient [redacted] the = Preoperative Case=20 Report Form, dated [redacted],noted that the required = [redacted],=20 [redacted], [redacted] was [redacted]. However, the = [redacted], [redacted] printout in this subject's file = noted the=20 count was [redacted] on [redacted], which was the 4-month=20 post-surgical visit. There was no record of the Preoperative = [redacted]=20 [redacted] in the subject's file.

Your written response to this observation is inadequate. In your = letter, you=20 stated that this subject had an [redacted] done on = [redacted] and=20 that the entry of the incorrect test result onto the Case Report Form = was "a=20 clerical error." You also attached a photocopy of a [redacted] = result=20 dated [redacted]. We note that the study subject number = [redacted]=20 was handwritten on this photocopy and, further that [redacted] = does not=20 correspond to any visit date required by the protocol. It is unclear = from your=20 letter whether the test performed on [redacted] was also in = error, since=20 this test was not required by the protocol for this particular visit, = and the=20 results of this test were not recorded on the Case Report Form for the = study=20 visit on [redacted]. As a clinical investigator, you are = responsible for=20 ensuring that all information reported as part of a clinical study is = accurate,=20 and you are also responsible for supervising personnel to whom you have=20 delegated certain study tasks.

ii . A monitoring report for the [redacted], = [redacted],=20 [redacted] study, dated 12/3-4/2004, noted that the Case Report = Forms for=20 nine study subjects had inconsistent and discrepant data, as compared to = the=20 source record, for such things as medications, [redacted],=20 [redacted], [redacted], [redacted] complications. = In=20 addition, the report noted that clinical records were not available to = verify=20 specific study visit information reported on the Case Report Forms for = subjects=20 [redacted], [redacted], [redacted] and=20 [redacted]

This was a repeat violation from an inspection that was conducted = in=20 October 2001, for which you subsequently received an Untitled Letter = from FDA on=20 December 12, 2001.

2. Failure to ensure an investigation is conducted according to = the signed=20 agreement, the investigational plan, and applicable FDA regulations [21 = CFR=20 812.100].

Responsibilities of clinical investigators include ensuring that an=20 investigation is conducted according to the signed agreement, the=20 investigational plan and applicable FDA regulations, and for protecting = the=20 rights, safety and welfare of subjects under the investigator's care [21 = CFR=20 812.100].

a. [redacted] Study Patient = [redacted]-[redacted]: an=20 [redacted] of the affected [redacted] was not performed=20 pre-operatively as required by the protocol.

b. A monitoring report for the [redacted], [redacted],=20 [redacted] study, dated 12/3-4/2004, noted that several study = procedures=20 required by the protocol were not performed, including:

i. [redacted] measurements for subjects [redacted],=20 [redacted], [redacted] and [redacted]
ii.=20 [redacted] counts for subjects [redacted], = [redacted],=20 and [redacted]
iii. Manual [redacted] measurements for = subject=20 [redacted]

3 . Failure to ensure submission,of complete, accurate, and timely = progress reports as required by the reviewing IRB [21 CFR = 812.150(a)].

Responsibilities of clinical investigators include submitting = progress=20 reports on the investigation to the reviewing IRB at regular intervals = [21 CFR=20 812.150(a)(3)], and providing upon request by a reviewing IRB, accurate, = complete, and current information about any aspect of the investigation = [21 CFR=20 812.150(a)(7)] .

You failed to adhere to the above stated = regulations.=20 Examples of these failures include but are not limited to the = following:

a. [redacted], [redacted], [redacted] was the = IRB of=20 record for the [redacted] study. Required study status updates = from you=20 every six months to approval. Your study records indicated that the = progress=20 report that was due on 10/6/03 was not sent to the IRB until 1/21/04, = despite=20 several reminders from the IRB. The progress report that was due on = 10/6/04 was=20 not sent to the IRB until 11/26/04.

Your written response to this observation is inadequate. In your = letter, you=20 stated that you "did not recognize at the onset of the study that a = quarterly=20 report was expected" and that you were not aware of your omission "until = contacted with a late notice." However, the letters from the IRB = indicate that=20 the progress reports were requested before the "Final Notice" requests = were=20 sent. Specifically, the January 13, 2004, letter from the IRB states = "The Board=20 understands you have been contacted several times," and the November 17, = 2004,=20 letter from the IRB indicates they were enclosing "another copy" of the = progress=20 report form for your completion. Furthermore, as a clinical = investigator, it is=20 your responsibility to understand any conditions of IRB approval, = including=20 frequency of progress reports.

The deviations presented in this letter are not intended to be an=20 all-inclusive list of objectionable practices that may exist at your = clinical=20 site. It is your responsibility to ensure adherence to each requirement = of the=20 Act and all pertinent Federal regulations when conducting clinical = research, and=20 to ensure that any study staff or personnel who are delegated study = tasks are=20 knowledgeable regarding the Investigational Plan and are directly = supervised by=20 you.

Please acknowledge receipt of this letter within 15 working days, = including=20 supporting documentation of the specific steps you have taken or will = take to=20 correct these violations and prevent the recurrence of similar = violations in=20 current and future studies.

In addition, please provide a complete list of all clinical trials in = which=20 you have participated for the last five years, including the name of the = study=20 and test article, the name of the sponsor, the number of subjects = enrolled, and=20 the current status of the study.

Our review of the inspection results also noted that you use an = electronic=20 medical record (EMR) system to maintain medical and other clinical data = for your=20 patients, including study subjects . You told Mr. Steyert that data = obtained=20 during study visits are entered directly into the EMR, and no paper = records are=20 used. A follow-up letter from you to Mr. Steyert, dated January 31, = 2005,=20 detailed the name of the EMR system and the means by which study subject = information is entered. Please note that Title 21, Code of Federal = Regulations,=20 Part 11, "Electronic Records; Electronic Signatures" outlines specific=20 requirements that must be met for any system that is being used to = maintain=20 required records . In addition to the information requested above, = please submit=20 the following:

Failure to respond to this letter and take appropriate corrective = action=20 could result in regulatory action without further notice. Please respond = in=20 writing to:=20

Food and Drug Administration
Center for Devices and Radiological = Health,=20 Office of Compliance Division of Bioresearch Monitoring, Special = Investigations=20 Branch (HFZ-311)
2094 Gaither Road, Rockville, Maryland 20850
Attn = :=20 Michael E. Marcarelli, PharmD/Director

A copy of this letter has been sent to FDA's New York District = Office, Food=20 and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. We = request=20 that you copy the district on your response.

Sincerely yours,
/s/

Larry D. Spears for Timothy A. Ulatowski
Director
Office of=20 Compliance
Center for Devices and Radiological Health

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