Inspections, Compliance, Enforcement, and Criminal Investigations
Covidien LP 6/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
One Montvale Avenue
June 14, 2012
Mr. Jose E. Almeida
President and CEO
15 Hampshire Street
Mansfield, Massachusetts 02048
Dear Mr. Almeida,
During an inspection of Covidien, LP, located in North Haven, Connecticut, on January 13, 2012, through February 09, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical staples and single-use loading units, such as the DUET Tissue Reinforcement System (TRS) Reload (Staple, Implantable). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351(h), in that 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Mr. Garrett B. Raymond, Vice President Global Quality Assurance and Regulatory, dated February 24, 2012, concerning our investigators' observations noted on the Form FDA 483 (FDA 483) List of inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to implement your firm's procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, your firm failed to initiate a corrective and preventative action (CAPA) after the review of quality data based on trend, criticality, recurrence, and correlation obtained from complaints and adverse events to ensure the proper course of action would be undertaken as described in your firm's procedure, (b)(4). Despite receiving numerous complaint, adverse event, and serious adverse event information since May of 2009 regarding use of the DUET TRS, a CAPA investigation was not initiated until January 19, 2012 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.
The response dated February 24, 2012, is not adequate. Your firm's response provides four factors explaining why your firm believed that a CAPA for these events was not required in accordance with your firm's standard operating procedures. However, your firm did not provide a description or evidence of implementation of a correction or corrective action, including retrospective review of complaints to ensure that documented corrective actions were implemented, for the complaints received for abdominal indications of use for similar patient injuries/deaths.
2. Failure to promptly review, evaluate, investigate, and maintain any complaint that represents an event that must be reported to FDA under Part 803, Medical Device Reporting, as required by 21 CFR 820.198(d).
For example, your firm has received reports of deaths and serious injuries associated with the use of the DUET TRS Reload since 2009, as shown in your firm's monthly tracking graphs. However, your firm failed to document investigations into deaths and serious injuries that resulted in issuance of a Safety Alert for use of the DUET TRS Reload in Japan in March 2011. When investigators requested documentation covering the investigations of these complaints, your firm provided interoffice emails that related to two trips to Japan taken by one of your firm's medical officers. When the investigators inquired why these emails were the only documentation available, a letter was provided to one of the investigators explaining your firm's reasoning, as the documentation requested was not kept in an organized state in the normal course of business.
The response dated February 24, 2012, did not address this violation because it was not cited on the FDA 483.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the vioiations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to: New England District Office, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. Refer to the Unique Identification Number CMS case# 282277 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Bruce Ota at (781) 587-7487.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
New England District
Mr. Garrett B. Raymond
Vice President Global Quality Assurance and Regulatory Affairs
60 Middletown Ave
North Haven, CT 06473