Inspections, Compliance, Enforcement, and Criminal Investigations
Department of Health and Human Services
Public Health Service
April 18, 2005
RETURN RECEIPT REQUESTED
Mr. Gary C. Restani
200 Headquarters Park Drive
Skillman, NJ 08558
Dear Mr. Restani:
During an inspection of your firm, ConvaTec., located at 200 Headquarters Park Drive, Skillman, NJ between January 27, 2005-February 8, 2005, investigators from the Food and Drug Administration (FDA) reviewed your records for the following products: Sur-Fit Natura Durahesive Moldable Convex; Sur-Fit Natura SH Wafer; Aquacel-Ag Hydrofiber dressing ; Active Life Cvx Drain Durahesive Pch. These products are medical devices within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
The above-stated inspection revealed that your 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 manufacturing, packaging, storage, or installation are not in conformance with the Quality System Regulation (QSR) for medical devices as set forth in Title 21, Code of Federal Regulations (CFR) Part 820. The deviations from QSR include, but are not limited to, the following:
1. Failure to investigate any complaints pertaining to injury, death, or any hazard to safety as required by 21 CFR 820.198(d). For example:
A) There was no record of an investigation for Aquacel-Ag Hydrofiber dressing (lot # 2J59815" [redacted]; An adverse event associated with the device, involving the deal of a child, was reported by your firm. However, your firm did not investigate if the device failed to meet specifications.
B) There was no record of an investigation for Sur-Fit Natura Durahesive Moldable Convex (Ostomy wafer) device for lot # 31368002 ([redacted]). An adverse event was reported by your firm regarding a patient's bleeding stoma associated with your Ostomy wafer. The laceration of the stoma required medical intervention (sutures of the patient's stoma) in order to prevent permanent impairment/damage.
C) There was no record of an investigation for complaint case report [redacted] which documents that an injury occurred. Specifically, the patient's artery was reported cut, which resulted in the pouch filling with blood while using your Sur-Fit Natura SH Wafer (lot # 1F47396) . The patient required medical intervention at a hospital in order to stop the bleeding. Your firm did not investigate if the device failed to meet specifications.
2. Complaints involving the possible failure of a device to meet any of its specifications were not investigated as required by 21 CFR 820.198(c): For example:
A) There were no documented investigations for complaint case reports, [redacted] and [redacted] which both document a pouch film separation from mass while using your Active Life Cvx Drain Durahesive Pch device (lot # 3K72793). Your firm needs to identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems as required by 21 CFR 820.100(a)(3).
Additionally, the inspection revealed that your devices are misbranded within the meaning of Section 502(t)(2) of the Act (21 U.S.C. § 352(t)(2)), in that your establishment failed to submit information to the Food and Drug Administration as required by 21 U.S.C. § 360i and the Medical Device Reporting (MDR) Regulation, as specified in 21 CFR Part 803 . Specifically, you failed to submit an MDR report to FDA within 30 days after receiving information which reasonably suggested that one of your commercially distributed devices may have caused or contributed to a death or serious, injury, as required by 21 CFR 803 .50(a)(1). Complaint case report documents that an injury occurred (patient's artery was reported cut, which resulte in the pouch filling with blood) while using your Sur-Fit Natura SH Wafer. The report documents that the patient required medical intervention at a hospital in order to stop the bleeding.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and on the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems within your establishment's quality system . You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective and preventive actions.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice to you. These actions include, but are not limited to, seizure, injunction and/or civil monetary penalties.
We have received your written response dated March 1, 2005 to the list of FDA 483 observations . Your response to observation one does not provide any information on how your firm will be able to determine if a complaint is or is not reportable to the FDA (Your firm needs to investigate the event in order to know if it should be reported). In addition, your res onse to observation one states that your firm is not following procedure [redacted] (Adverse Event Handling Procedure for Marketed Products). How will the changes to the written procedures discussed in your response provide us with assuranee-of satisfactory corrective actions when you determined through an investigation that your firm is not following your own written procedures?
As stated above, firms are required to investigate every device-related death, serious injury, and malfunction by the Quality System/GMP regulation, 21 CFR 820 .198 and the MDR regulation, 21 CFR Part 803.
Please notify this office in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. Your response should be directed to the New Jersey District, FDA, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Robert J. Maffei, Compliance Officer.
Douglas I. Ellsworth
New Jersey District