Inspections, Compliance, Enforcement, and Criminal Investigations
Seecor, Inc. 16-Dec-05
Department of Health and Human Services
Public Health Service
December 16, 2005
RETURNED RECEIPT REQUESTED
Jack E. Burroughs, President
844 Dalworth Drive, Suite 6
Mesquite, TX 75149
Dear Mr. Burroughs:
Between October 17 and 28, 2005, the United States Food and Drug Administration (FDA) conducted an inspection of Seecor, Inc., at the above referenced address. The FDA investigators determined that your firm manufactures the Stat-Pace II Transesophageal Cardiac Pacer (external pulse generator) and the AC Fibrillator Model 2039. These products are devices, as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
FDA's inspection revealed that your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)) because the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Your devices are also misbranded within the meaning .of Section 502(t)(2) of the Act (21 U.S .C. § 352(t)(2)) because your firm failed to establish and maintain adequate written medical device reporting (MDR) procedures, as required by Section 5'19 of the Act (21 U.S.C. § 360i) and the MDR Regulation, 21 C.F.R. Part 803.
At the close of the inspection, FDA issued to you a list of Inspectional Observations, Form FDA-483. The FDA documented your numerous, significant violations of the QS and MDR regulations in the Form FDA-483.
On November 30, 2005, FDA received your firm's response to the Form FDA-483 (hereafter, "your response"). Your response, however, does not establish that you have adequately corrected all of the violations noted in the Form FDA-483. The following list identifies several of the significant violations noted on the Form FDA-483, and it addresses your response to the listed violation:
1. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. § 820.198(a). [FDA-483 Item 10]. Your firm does not document and evaluate complaints in accordance with your firm's "Complaint Processing" procedure. For example, in 2003, your firm received two oral user reports that alleged the possible failure of two AC fibrillators occurring during surgery. You explained to the FDA investigators that the devices "burned up" due to user error. However, your firm failed to: (a) conduct and document a formal complaint investigation to confirm or not confirm the incidents; (b) document the nature and details of the incidents; (c) document your follow-up with the users; (d) document your justification for why you did not consider the oral user reports as complaints; and (e) document your determination of whether any adverse medical event had occurred during surgery.
Your response to this observation is not adequate. You still have not fully documented this incident. For instance, you did not document whether the incident occurred during surgery, and, if so, what happened to the patients involved. Additionally, you have failed to explain the specific steps your firm will take to prevent this incident from happening in the future. Moreover have failed to provide a copy of the user report of the incident an investigation of the user report to FDA.
2. Failure to adequately analyze sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems,and a failure to document all corrective and preventative action activities. required by 21 CFR §§ 820.100(a)(1) and (b). [FDA-483 Item 9]. Your firm does not analyze or evaluate complaints for the Tapsystem Model2A to determine whether any product quality problems exist. You verbally stated that you reviewed these complaints but did not document your review.
Your response to this observation is not adequate until you: (a) thoroughly conduct and document your review of the product complaints and of the [redacted] quality reports provided by [redacted] relating to the Tapsystern Model 2A; and (b) provide FDA with a copy of your review report.
3. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, and a failure to document the relevant acceptance activities, as required by 21 CFR §§ 820.80(d) and (e). [FDA-483 Item 2 and 3]. Your firm does not maintain records or documentation of the [redacted] burn-in testing and the testing procedures are not defined. For example:
a) Although your firm has a written [redacted] burn-in testing procedure or the Stat-Pace II cardiac pacers and the AC fibrillators, your firm failed to revise the procedures to specify who is responsible for conducting the burn-in testing. During the inspection you verbally explained that sometimes your firm conducted the [redacted] burn-in testing; other times your contract manufacturers conducted a [redacted] burn-in testing, and then your firm conducted the remaining [redacted] burn-in testing.
b) Your firm failed to maintain records of the [redacted] or [redacted] burn-in testing.
c) The bum-in testing procedures for both devices failed to define specific test conditions, acceptance criteria, and types of inspection, test, and measuring equipment used to demonstrate how your firm detects premature device failures and verifies the devices' conformance with their approved specifications during the burn-in testing.
Your response to this observation is not adequate. You have failed to explain: (a) who performs the [redacted] burn-in testing; (b) the test parameters that are measured across a device's output terminals and their acceptance criteria; and (c) the specific attributes or data your firm evaluated and documented to detect premature device failures during the burn-in testing.
4. Failure to establish and maintain process control procedures that include documented instructions, standard operating procedures (SOP), and methods that define and control the manner of production, as required by 21 CFR § 820.70(a)(1). [FDA-483 Item 5]. Your firm has not established adequate written procedures or instructions to describe the work-flow process conducted by your firm and by the contract manufacturers. Some production process controls at your firm and at your contract manufacturers are verbal in nature and are not documented. For example:
a) Your firm failed to define the specific steps of the "Fibrillator Check Out" procedure that are performed by your firm and that are performed contract manufacturers.
b) During the inspection you verbally provided inconsistent information concerning who is responsible for adding a specific component devices. You initially said that you added the component assembled devices that you received from the contract manufacturers. However, you later said that the contract manufacturers added this component. This information was not documented.
Your response to this observation is not adequate unless and until you provide FDA with evidence establishing that you have implemented written SOPs and other procedures that address items 4(a) and (b).
5. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21§ 820.50(a)(1). [FDA-483 Item 6]. Your firm does not have written purchasing control procedures or documentation that all suppliers have been evaluated and selected on the basis of their ability to meet specified requirements. For example, your firm failed to provide any documentation establishing that it conducts a routine evaluation of the contract manufacturers' quality of work. Instead, you merely stated that you trust their work and that their history with your firm was sufficient. However, [redacted] has sent you their complaint records, which document 21 product issues since 2003. Your firm has not determined whether these product issues are related to the contract manufacturer's operations.
Your response to this observation is not adequate. You have failed to explain whether and how you will conduct and document your quality review of the contract manufacturers assembly and testing procedures.
6. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups, as required by 21 CFR § 820.60. [FD-483 Item 4]. You firm did not have written procedures for identifying product throughout the manufacturing and distribution process. For example, your firm did not establish written procedures explaining the meaning of the temporary device assembly serial numbers of the AC fibrillators (e.g., A, B, C, D, etc.) assigned by the contract manufacturers and a written procedure explaining how your firm assigned a final device serial numbers. A review of the device history records for the AC fibrillators documented that your firm had shipped two AC fibrillators with the same device serial to two separate customers.
Your response to this observation is not adequate. While you explained that each device has been assigned a control code, you have not established specific written instructions or procedures to explain the meaning of each control code for the devices manufactured and delivered by your contract manufacturers.
7. Failure to establish and maintain procedures to control all documents required by the QS regulation, as required by 21 CFR § 820.40. [FDA-483 Item 11]. Your firm has not implemented procedures to control required documents regarding the production processes for the manufacture of the AC Fibrillator Model 2039 and the Stat Pace II. For example, procedures for the burn-in and final product testing, assembly of the main circuit board, and receiving inspection: (a) are undated and unsigned; (b) contain changes that do not include a description of the changes and dates of the changes and approval; and (c) do not have a document version number to differentiate the
version from the obsolete version.
Your response to this observation is not adequate until you complete the revisions of your existing procedures to ensure compliance with the QS regulation and you provide FDA with documentation of your revised procedure.
Medical Device Reporting Requlation
'I . Failure to develop, maintain, and implement adequate written procedures, as required by 21 CFR § 803.17. [FDA 483 Item 12]. Your MDR procedures (dated 10/23/95) have not been revised to reflect changes that have been implemented in the current MDR regulation which became effective after you implemented your current MDR procedure. For example
a) Your firm does not define a standardized review process and procedure to determine whether incoming complaints meet the criteria for an MDR reportable death, serious injury, or malfunction.
b) Your firm does not require that MDR reportable events are promptly reviewed, evaluated, investigated, and reported to FDA and that records of investigation contain certain investigational elements.
c) Your firm does not define the MDR malfunction reporting requirements.
d) Your firm is required to submit to FDA a written report (Medwatch Form 3500A) for each reportable adverse event within the 30-day time frame.
e) Your firm does not define the two types of five-day reports.
f) Your firm does not establish a MDR event file which contains or includes all adverse event information in your firm's possession, including documentation of the deliberations and decision making process used to determine if an event was or was not reportable.
Your response to this observation is not adequate until you actually establish and implement complete, written MDR procedures and you maintain a MDR event file in accordance with the current MDR regulations at 21 CFR Part 803.
Responding to This Letter
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 the regulations. The specific violations noted in this letter and in the Form FDA- 483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
Several of the violations noted above were observed during FDA's previous inspection of your facility in July 2002. FDA is seriously concerned about your firm's repeated failure to comply with the Act and FDA regulations. Therefore, you should conduct a comprehensive review of your firm's manufacturing and quality assurance systems, and you must take immediate action to correct all violations of the Act and FDA regulations. Failure to promptly correct your firm's 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/or civil penalties.
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 applications for premarket approval to which the QS regulation deficiencies are reasonably related will be 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.
Please notify this office in writing within 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 timeframes 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 ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW940, 4040 N Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter; please contact Thao Ta at 214-253-5217.
Dallas District Director