Inspections, Compliance, Enforcement, and Criminal Investigations
UCA, LLC 08-Nov-06
Department of Health and Human Services
Public Health Service
New Orleans District
November 8, 2006
WARNING LETTER NO. 2007-NOL-03
Mr. Louis Wallace, President/CEO
200 River Hills Drive
Nashville, Tennessee 37210
Dear Mr. Wallace:
On August 29 and 30, 2006, a U.S. Food and Drug Administration (FDA) investigator inspected your facility UCA, LLC, located at 1650 Elm Hill Pike, Building 5, Nashville, Tennessee. The investigator documented serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). The sterilization container systems manufactured for your firm are devices within the meaning of Section 201(h) of the Act [21 United States Code (USC) 321 (h)] because they are intended for use in the sterilizing of other devices used in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). These violations include, but are not limited to, the following:
1. Corrective and preventive action (CAPA) activities have not been documented by your firm, including analysis of sources of quality data, investigations of causes of nonconformities, the actions needed to correct or prevent recurrence of nonconforming product and other quality problems, the verification or validation of corrective actions, implementation of corrective and preventive actions, dissemination of information about quality problems or nonconforming product to responsible parties, and submission of information on quality problems and corrective and preventive actions for management review, as required under 21 CFR 820.100(b).
a. Your documentation for CAPA activities is limited to two incomplete corrective/preventive action forms.
b. There is no evidence to show the return materials authorizations (RMAs/complaints) are analyzed. The investigator's review, during the current FDA inspection, of your firm's RMAs, dated February 13, 2006 through August 28, 2006, revealed thirteen of fifty-one RMAs involved broken latches on sterilization container systems. There was no documentation available at your firm to demonstrate this data was analyzed, the causes were investigated, the problems were corrected/prevented, or any corrections were verified or validated.
2. Your firm had no device history records available for review to demonstrate the sterilization container systems were manufactured in accordance with your firm's device master record, as required under 21 CFR 820.184.
The above violations are not intended to be an all-inclusive list, as other deficiencies may exist at your facility. It is your responsibility to assure your facility is operating in compliance with each requirement of the regulations and applicable statutes enforced by the FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts.
You should take prompt action to correct the violations noted in this letter, and you should establish procedures whereby such violations do not recur. Failure to promptly correct violations may result in regulatory action without further notice, such as seizure, injunction, and/or civil money penalties.
We are aware [redacted], made a verbal commitment to correct the observed deficiencies during the inspection. However, you should notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If you cannot complete all corrections before you respond, you must explain the reason for your delay and state when you will correct any remaining deviations. Your responses will be reviewed and any further corrective actions will be verified during our next inspection at your facility. You can find guidance and information for regulated industry regarding regulations for devices through links at FDA's website at http://www.fda.gov/oc/industry/.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Ms. Batey at (615) 366-7808.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483
1650 Elm Hill Pike, Building 5
Nashville, TN 37210