Inspections, Compliance, Enforcement, and Criminal Investigations
Xttrium Laboratories, Inc. 30-Dec-03
Department of Health and Human Services
Public Health Service
Chicago District Office
December 30, 2003
Return Receipt Requested
Kevin S. Greevy, President
Xttrium Laboratories, Inc.
415 West Pershing Road
Chicago, IL 60609
During the period from May 12 through June 23, 2003, Investigators Debra Love and Lisa Lewis conducted an inspection of your firm, located at the same address, to determine your firms compliance with the Postmarketing Adverse Drug Experience (PADE) reporting requirements of Section 505 (k) of the Federal Food, Drug and Cosmetic Act (the Act), and Title 21, Code of Federal Regulations, (CFR), Part 314.80.
Based on our review of the inspectional findings, we conclude that your firm failed to with Section 505 (k) (1) requires an applicant to establish and maintain records, and report data relating to clinical experience and other data of information for drugs for which an approval of an application filed under 505(b) or 505 (j) is in effect.
Deviations from 21 CFR 314.80 include the following:
1. Failure to develop adequate written procedures for surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA as required by 21 CFR 314.80 (b). Specifically, QA sop 14-1, Adverse Drug Reactions, effective September 10, 2002, did not cover subjects covered by the applicable regulations, including:
a. Submission of 15 day alert reports [314.80 (c) (1) (i)]
b. Postmarketing 15-day report follow-up investigation and report submission [314.80 (c) (1) (ii)]
c. Periodic adverse drug experience reports [314.80(c) (2)]
d. Use of reporting form FDA 3500A [314.80(f)]
e. Recordkeeping [314.80(i)].
2. Failure to submit required periodic adverse drug experience reports for your approved chlorhexidine gluconate products under NDA 20-111, NDA 19-422, NDA 19-125, and NDA 19-127 as required by 21 CFR 314.80(c)(2). Adverse drug experience data is required to be reported in a periodic adverse drug experience report if not reported as a 15-day alert report.
Your firm received the following adverse drug experience data, but did not submit adverse drug experience reports with this data within the required 60 day period.
#990121 dated 01/21/99
#990602 dated 06/02/99
#990602-A dated 06/02/99
#000214 dated 02/14/00
4% Betasept, Lot 1061-299
0.75% Prima-Kare, Lots 1175-37 & 1175-38
2% Bactoshield, Lots 810-487
4% Calgon Vestal 2% CHG, Lots 907-574,907-566
Neither the above identification of violations nor the Form FDA 483, Inspectional Observations, issued and discussed with you at the conclusion of the inspection are intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with each requirement of the Act and its regulations.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. These actions include, but are not limited to, seizure or injunction. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.
We acknowledge receipt of the July 23, 2003 letter from Ram Chakroborty, PhD, Vice President, which contained the response to the Form FDA 483 issued and discussed with you at the conclusion of the inspection. The promised corrections discussed in the response do not appear to adequately address the deviations. Submitted with the response was a copy of your revised SOP 14-4, Adverse Drug Reactions, effective June 18, 2003, which replaced SOP 14-1. This revised procedure is inadequate in that the document does not:
a. Discuss procedures for the medical evaluation of postmarketing adverse experiences.
b. Include procedures to ensure that postmarketing 15-day alert reports are promptly investigated and follow-up reports are submitted within fifteen days of receipt of new information, and records maintained of unsuccessful steps taken to seek additional information.
c. Discuss the distinction between a required periodic adverse drug experience report versus the 15 day alert report requirement
d. Contain sufficient information regarding what information to report, where to report this information, and when to submit ADE reports to FDA.
An evaluation of your firms implementation of the corrective measures discussed in the FD 483 response will be evaluated during the next inspection of your firm.
Please submit in writing, within 15 working days of receipt of this letter, your responses to the violations identified in this letter. If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be submitted to the attention of Compliance Officer George F. Bailey, at the above address.
Acting District Director