Inspections, Compliance, Enforcement, and Criminal Investigations
Central Brooklyn Medical Group, P.C. 24-Mar-03
Food & Drug Administration
300 Pearl Street, Suite 100
Buffalo, NY 14202
March 24, 2003
WARNING LETTER NYK 2003-17
RETURN RECEIPT REQUESTED
Jeffrey Cohen, M.D.
Central Brooklyn Medical Group, P.C.
1000 Church Avenue
Brooklyn, New York 11218
RE: Facility ID Number 186015
Dear Dr. Cohen:
A representative of the New York City Department of Health, acting on behalf of the United States Food and Drug Administration (FDA), conducted an inspection of your facility on March 5, 2003. This inspection revealed a serious regulatory problem involving the mammography at your facility.
Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. 263b, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following Level 1 finding at your facility:
Phantom quality control records were missing for more than four (4) weeks for the [redacted] mammography unit. Specifically, there no phantom quality control records for the period of April 2002 through July 2002 when the unit was used to perform mammography (see 21 CFR 900.12(d)(2), 900.12(e)(2)).
The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. This problem is identified as Level 1 because it identifies a failure to meet a significant MQSA requirement.
This condition represents a violation of the law, which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, placing your facility under a Directed Plan of Correction, charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with MQSA standards, suspension or revocation of your facility?s FDA certificate, or obtaining a court injunction against further mammography.
It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date that you receive this letter each step your facility is taking to correct this violation and to prevent the recurrence of similar violations.
In addition, your response should address the Level 2 observations listed on the inspection report. The Level 2 observations noted include the following:
- The [redacted] x-ray unit [redacted] is not accredited(see 21 CFR 900.11(a)).
- Phantom quality control records were missing for three weeks for the Specifically, there were no phantom quality control records for the weeks of 11/11/02, 11/18/02, and 12/23/02 when the unit was used to perform mammography (see 21 C.F.R. 900.12(d)(2), 900.12(e)(2)).
- The medical physicist?s survey for the [redacted] x-ray unit [redacted] is incomplete because the artifact evaluation was inadequate (see 21 CFR 900.12(e)(5)(ix).
Please submit your response to the attention of Lisa M. Utz, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, NY 14202, telephone (716) 551-4461 ext. 3117.
Finally, you should understand there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA?s requirements for mammography facilities by
contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, Maryland 21045-6057 (l-800-838-7715), or through the Internet at http://www.fda.gov
Jerome G. Woyshner