Inspections, Compliance, Enforcement, and Criminal Investigations
Remington Medical Inc 27-Aug-04
Department of Health and Human Services
Public Health Service
Atlanta District Office
August 27, 2004
VIA FEDERAL EXPRESS
Fredrick L. Aycock
Chief Executive Officer
Remington Medical, Inc.
6830 Meadowridge Court
Alpharetta, GA 30005-2202
Dear Mr. Aycock:
During an inspection of your firm located in Alpharetta, Georgia, conducted over 30 days beginning on April 14, 2004 and ending on July 7, 2004, United States Food and Drug Administration (FDA) Investigators, Paul W. Moy and Chateryl K. Washington, determined that your firm manufactures sterile disposable surgical cables, biopsy and prostate seeding needles, drainage bags, high pressure tubings, introducer kits, and general utility trays. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above stated inspection revealed that your firms procedures and practices are not in conformity with the requirements of the Quality System (QS) regulation, Title 21 Code of Federal Regulations (CFR) Part 820 and the Medical Device Reporting(MDR) regulations, Title 21 CFR Part 803. These violations of the QS and MDR regulations, cause the devices you manufacture to be adulterated within the meaning of Section 501(h) of the Act and misbranded within the meaning of Section 502(t)(2) of the Act.
Quality System Regulation
The investigators noted the following violations of the QS regulation:
1. Your firm failed to establish and maintain procedures for finished device acceptance to ensure that each production lot or batch of finished devices meets acceptance criteria; and that finished devices shall be held in quarantine or otherwise adequately controlled until released, as required by 21 CFR 820.80(d) (FDA 483, Items #5 & 6). Specifically:
a. Endotoxin testing was not being performed on each finished product lot that was promoted and labeled as being non-pyrogenic, such as Disposable Surgical Cables FL-601-97, Introducer Sets, and Automatic Cutting Needles, before the lot was released;
b. Sterility Testing Procedure 10B-SOP-0083 allowed for products to be tested only in [redacted] media at [redacted]C for 14 days, even though your firm does not have any data or studies showing the types of organisms which exist on products and in the environment which could survive the sterilization cycle and may require a different media for culturing; and
c. Finished devices were released for distribution prior to completion of activities required in the Device Master record. The Magnum Automatic Cutting Needles were not being tested under simulated use conditions as specified in the device master record.
2. Your firm failed to document corrective and preventive action activities including investigations of the cause of nonconformities, actions needed to correct or prevent recurrence of nonconforming product and other quality problems, and implementation of corrective and preventive actions, as required by 21 CFR 820.100(b) (FDA 483, Item # 1). Specifically:
a. There were no written records showing failure investigations being conducted and preventive actions being implemented in response to biological indicator failures involving but not limited to the following lots: General Utility Tray System, Lot 031396 in Sterilization Load 176034; Disposable Surgical Cable, Lot 011901 in Sterilization Load 193012; and Drainage Bag, Lot 040149 in Sterilization Load 047044;
b. Several lots in Sterilization Load 134023 were released without any documented biological indicator testing results. No corrective or preventive actions were implemented to prevent recurrence of this situation; and
c. No documentation of investigations and/or corrective actions taken to prevent problems from recurring when non-conformance reports pointed to holes and bad seals in the outer pouches of various products including but not limited to Disposable Surgical Cable and Guidewire Introducer Needle.
3. Your firm failed to identify and implement the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3) (FDA 483, Item #3). Specifically:
a. Corrective actions in response to complaints concerning unmarked Chiba Needles in Lots 021764 and 021337 and incorrectly marked Prostate Seeding Needles in Lot 020535 or 022681 did not include products in distribution and in inventory. Also, your firm did not update incoming specifications to include inspection for proper markings;
b. The reworking of Magnum Automatic Cutting Needles from NAC-1825M/Lot 031631 because of burrs and sticking problems did not involve product in distribution; and
c. Records for Magnum Automatic Cutting Needles (Lots 031101 & 031533) did not show that these lots were reworked or reinspected even though it was confirmed in returned items that the needle sticking problem was due to burrs.
4. Your firm failed to adequately validate manufacturing and sterilization processes according to established procedures, as required by 21 CFR 820.75(a) (FDA 483, Item #4). Specifically:
a. Half cycle sterilization validation runs did not include any consecutive reproducible studies involving full chambers. By not using full chambers during your validation studies, your firm has not addressed the impact and/or adequacy of using full chambers on the sterilization process;
b. Most of the minimum and maximum temperatures and percent relative humidity readings at specified times in the, [redacted] half cycle and [redacted] cycle sterilization validation runs in Study S-01-04 for Ethylene Oxide-Cabinet [redacted] differed from the original [redacted] readings which were printed from a disk on 5/6 & 7/04. Also, half cycle Run #1, [redacted] recorded temperatures that were less than the minimum required temperature for the entire sterilization dwell time. [redacted] recorded temperatures that there within specification for only one hour and 37 minutes of the sterilization dwell time; and
c. The validation of the [redacted] Sealer with [redacted] pouches at minimum and maximum sealing parameters did not include any consecutive reproducible runs, involving the smallest and largest pouch sizes.
5. Your firm's complaint investigation records failed to include the dates and results of the investigation as well as a reply to the complainant, as required by 21 CFR 820.198(e). Specifically, the following: complaints did not have any records of failure investigations, examination/testing of returned items, assessment of the complaint, and a reply to the complainant (FDA 483, Item #2):
a. Complaints pertaining to bad core samples, associated with Magnum Automatic Cutting Needles from NAC-1825M Lots 031631, 032261, and 033366 and NAC-1820B/ Lot 031541;
b. Complaints 27303, 27403, & 04304 concerning sticking Magnum Automatic Cutting Needles;
c. Complaints 04804,00904,08403 & 11403 (2) involving malfunctions due to dimension problems with Magnum Automatic Cutting Needles; and
d. Complaint 12003 pertaining to a bent Marked Chiba Needle from CNM-2208/Lot 030225.
6. Your firm failed to implement procedure to ensure that complaints are properly evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3). Specifically, complaint 04704, received by your firm on 2/5/04 involving the disposable surgical cable in which the black plug portion broke in half (the black end came apart), was not properly evaluated to determine whether this incident represents an MDR reportable event. Your firm received the product for evaluation; however as of the end of the our inspection, results were still pending. (FDA 483, Item #8).
7. Your firm failed to fully monitor and control process parameters during production, as required by 21 CFR 820.70(a)(2). Specifically, the speed of air circulation fan in the Ethylene Oxide cabinet was not being monitored during the sterilization cycle. (FDA 483, Item #7)
8. Your firm failed to fully document acceptance activities, as required by 21 CFR 820.80(e) (FDA 483, Item #11). Specifically:
a. Certificates of conformance for incoming components did not include actual testing and/or inspectional results and measurements which were performed to release the lot; and
b. The sample size, specific acceptance activities performed, and actual inspection/testing results were not being documented for incoming components.
9. Your firm failed to document equipment calibration as required by 21 CFR 820.72 (a). Specifically, your firm did not have any records showing the calibration of all [redacted] before they were used to read and record temperature and percent relative humidity for various studies involving Ethylene Oxide cabinets. (FDA 483, Item #12)
Medical Device Reporting
The investigator noted that there was a failure to comply with a requirement prescribed under Section 519 of the Act as follows:
10. Your firm failed to file an adverse event report as required by 21 CFR 803.50(a)(1). Specifically, your firm failed to promptly report to the FDA an MDR-reportable complaint that was received by your firm on/about 6/17/03 concerning a patient who went into asystole. The user facility investigated the incident and determined that the connector at the pacemaker end of the disposable extension cable had a broken retaining clip and would not stay firmly seated in the pacemaker. The user facility notified you of this incident and submitted a Medwatch report. (FDA 483, Item #8).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. 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.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, actions for seizure, injunction, and/or civil money penalties. Additionally, no premarket submissions for Class III devices to which the QS regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no request for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing Within fifteen (15) working days of receipt of this letter of the specific steps you have taken, or will take, to identify and correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating that the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
We acknowledge receipt of a letter dated August 17, 2004 from Ms. Maria P. Granito, VP Operation/Regulatory. We are currently reviewing your response letter. You may refer to your August 17, 2004 response in your answer to this Warning Letter. Please send your response to the attention of Serene N. Ackall, Compliance Officer at the address noted in the letterhead. If you have any questions about this letter, you can contact Serene Ackall at (404) 253-1296.
Mary Woleske, Director