Inspections, Compliance, Enforcement, and Criminal Investigations
American Medical Specialties, Inc. 18-Jul-05
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
July 18, 2005
Richard A. Furlong, CEO
American Medical Specialties, Inc.
10750A Endeavour Way
Largo, FL 33777
Dear Mr. Furlong:
During an inspection of your establishment located in Largo, Florida from May 4-6, 2005, an FDA investigator determined that your establishment is a manufacturer (specification developer) of sterile and non-sterile bone screws (K-wires and Steinmann Pins) and various sterile and non-sterile surgical burs and blades. These products are medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h).
The investigator documented significant violations from the Quality System (QS) Regulation, Title 21, Code of Federal Regulations (CFR), part 820, and the Medical Device Reporting regulations, Title 21 CFR, Part 803. These violations cause the device(s) you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S.C. 351(h)] of the Act and misbranded within the meaning of Section 502(t)(2) [21 U.S.C. 352(t)(2)] of the Act.
The Quality System Regulation
The investigator noted the following violations of the QS regulations:
1. Your firm failed to validate a process that cannot be fully verified by subsequent inspection and test as required by 21 CFR 820.75 as follows:
a) The process validation of the sealing process (Doboy Heat Sealer) was incomplete for medical devices packaged and sent to your contract sterilizer. This is a repeat of FDA 483 item issued during the March 2004 inspection (FDA 483, Item #1A):
Your firm's response dated May 20, 2005 is inadequate because the corrections are proposed to be completed in the future and a protocol to direct and control the validation parameters was not provided. We cannot determine the adequacy of your response.
b) 65 samples sent to your contract laboratory on May 3, 2005 fail to constitute validation because they were collected from one sealing run; were sealed at a set point not along the entire range of acceptable temperature parameters; sealer alarms were not justified for the study; and sealing validation will not be completed due to the concurrent accelerated stability study (FDA 483, Item #1 B).
Your firm's response dated May 20, 2005 is inadequate as noted above in Item #1 a. Your response also fails to justify the alarm limits that appear to have been arbitrarily selected.
c) Your firm failed to conduct quarterly bioburden and verification dose audits. Only four bioburden tests have been conducted all of which were in October and November 2004. The verification dose audit was conducted at the routine sterilization dose and not at the verification dose of 10-2 @ 7.9 kGY and, failed to complete sterility tests on these samples until February 2005 (FDA 483, Item #1 C).
Your firm's response dated May 20, 2005 is inadequate because all corrections are promised in the future and the protocol to direct and control sterilization validation was not provided.
d) Validated sterilization recommendation instructions are not provided to end users for non-sterile devices, which are required to be sterile prior to use. This is a repeat of FDA 483 item issued during the March 2004 inspection (FDA 483, Item #1 D).
Your response dated May 20, 2005 is inadequate because corrective action is promised to be completed in the future and has not been tested and verified.
2) Your firm failed to implement complete corrective and preventive actions (CAPA) as required by 21 CFR 820.100(a). Your CAPA lacks the requirement that all corrective and preventive actions are to be verified/ validated prior to implementation and that they are not be detrimental to the finished device. No CAPA record exists addressing the impact on material (FDA 483, Item #7).
Your response dated May 20, 2005 to FDA 483, Item #2 appears to be adequate, and will be verified during the re-inspection of your firm.
3) Your firm failed to establish complete procedures for quality audits as required by 21 CFR 820.22. Your internal audit, criteria is not documented in the Internal Audit SOP and fails to include procedures addressing Medical Device Reporting (MDR) and/or Corrections and Removals (FDA 483, Item #8).
Your response dated May 20, 2005 is inadequate because it promises corrective action in the future and training will not be complete until June 15, 2005.
4) Your firm failed to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants as required by 21 CFR 820.50(a). Your firm's purchasing control is inadequate as follows:
a) Surgical Dissection is designated a contract manufacturer, however, they obtain the product from two other companies and there is no documentation covering these suppliers (FDA 483, Item #2A);
b) There is no verification to assure that your contract sterilizer conducts adequate calibration and maintenance of dosimeters and instruments such as spectrophotometers, micrometers, and your firm failed to audit the contract sterilizer (FDA 483, Item #2B);
c) Supplier Evaluation Surveys are required by your own procedures, however, none have been completed (This is a repeat FDA 483 item from the March 2004 inspection) (FDA 483, Item #2C).
d) Supplier Evaluation Surveys do not require objective evidence (FDA 483, Item #2D);
e) Your firm's incoming inspection of K-wires/Steinmann Pins fails to cover all specifications including: verification that specified material is used, checks to verify specified number of threads per inch, checks to verify specified depth of threads, and checks to verify specified length of threading from tip in partially threaded devices (This is a repeat FDA 483 item from the March 2004 inspection) (FDA 483, Item #2E);
f) Your firm's Purchasing SOP grandfathered all suppliers on the Approved Supplier List (ASL) as of March 2005. There is no documentation covering these suppliers except for ISO certificates (FDA 483, Item #2F);
g) Certificates of Compliance are not documented and verified as required (FDA 483, Item #2G).
5) Your firm failed to maintain device master records (DMRs) that include or refer to the location of device specifications as required by 21 CFR 820.181(a). Your firm lacks specifications for K-wires/Steinmann Pins. There are no drawings or other information covering specifications for materials used, number of threads per inch, depth of threads, and length of threading from tip in partially threaded devices (FDA 483, Item #3).
Your firm's response date May 20, 2005 is inadequate because the corrections are promised in the future and no documentation is provided to cover your firm's efforts to reverse engineer documents for specifications of your firm's devices.
6) Your firm failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications as required by 21 CFR 820.70(a). Documentation of visual inspection of package seals began on May 2, 2005. The inspection only includes a sample size pursuant to AAMI/ANSI Z.14 even though sealing validation has not been completed. This is a repeat FDA 483 item from the March 2004 inspection) (FDA 483, Item #5).
7) Your firm failed to establish procedures to control the design process as required by 21 CFR 820.30(a). There are no procedures established to control the device design. This is a repeat item from FDA 483 issued from the March 2004 inspection (FDA 483, Item #6).
Medical Device Reporting (MDR)
Your devices are misbranded within the meaning of section 502(t)(2) in that there was a failure to comply with a requirement prescribed under section 519 of the Act respecting the device as follows:
8) Your firm failed to submit a MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur as required by 21 CFR 803.50. Your firm failed to submit a User Facility Report, which was sent to American Medical Specialties on January 29, 1997, which reported an incident covering a condylectomy of the 3rd digit on the left foot with K-wire insertion. The podiatrist purported slight difficulty removing the wire and X-ray revealed approximately 1 inch of K-wire which was left in the patient's metatarsophalangeal joint as a MDR (This is a repeat FDA 483, item issued during the March 2004 inspection) (FDA 483, Item #4).
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 Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA.
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. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of any steps that you are still in the process of taking to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating 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 assure that similar violations will not recur.
Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Director, Florida District