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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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PDS Manufacturing, Inc. 24-Nov-08

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

November 24, 2008

Ref: 2009-DAL-WL-05



Mr. Michael W. Freitas, President and CEO
PDS Manufacturing, Inc.
577 Commerce Street, Suite A
Southlake, Texas 76092

Dear Mr. Freitas:

During an inspection of your firm located in Southlake, Texas, on August 25 through 27, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a cryosurgical system consisting of hand-held freezing modules, a refrigeration unit, and disposable tips that are intended to destroy tissue during surgical procedures by applying extreme cold temperature. 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 are intended 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, its manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

The FDA investigator issued the observations, which are listed on the Form FDA 483 (List of Inspectional Observations), to you at the end of the inspection. The Agency will conduct follow-up inspections to assure that your firm's corrections are adequate. These violations include, but are not limited to, the following:

Quality System Violations

1. Failure of the management with executive responsibility to ensure that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization, as required by 21 C.F.R. § 820.20. Specifically, your firm has not established a quality policy, appointed a management representative and documented the appointment, established internal quality audit procedures and conducted such audits, and conducted management reviews of your firm's quality system.

2. Failure to establish and maintain adequate procedures for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 C.F.R. § 820.100(a)(2); for identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 C.F.R. § 820.100(a)(3); for implementing and recording changes needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 C.F.R. § 820.100(a)(5); and for ensuring that information relating to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the preventions of such problems, as required by 21 C.F.R § 820.100(a)(6).

a. Specifically, your firm has not investigated and documented why 115 devices did not cool and their global board chips were replaced during the production period from 3/24/08 to 7/17/08, and implemented adequate corrective action. Two of the devices had this same chip replaced five times. There was no documentation that this quality issue was addressed with the manufacturer of the circuit boards or your employees.

b. In addition, documents collected during the inspection revealed additional violations. Specifically,

(i) Your firm has not investigated and documented why the [(b)(4)] seals had to be replaced for the 19 devices manufactured between August 2007 and July 2008.

(ii) Engineering Change Notice (ECN) 3265-0003 Revision A, dated 11/2106, documented "inconsistent contact of [(b)(4)] to [(b)(4)] causing temperature regulation issues," and Instruction Change Notice (ICN) 3265-0006 Revision L, dated 9/21/07, documented "unclear how to assemble [(b)(4)] with [(b)(4)] contact piece."

Both the ECN and ICN were not signed by the designated individual(s) to demonstrate your firm's approval and implementation of the manufacturing changes. Your firm has not conducted effectiveness checks and documented their results to show whether the added components or revised assembly steps actually fixed the quality problems.

3. Failure to identify, document, and approve the acceptance status of product, and indicate the conformance or nonconformance of product with acceptance criteria to ensure that the only product which passed the required acceptance activities is distributed, used, or installed, as required by 21 C.F.R. § 820.86. Specifically, documents collected during the inspection revealed that 25 devices that had a problem with possible diode assembly errors, as documented in your Deviation Acceptance Report (DAR) 3265-00-0000-A, dated 9/21/07, were reportedly reworked before shipment. Neither your firm nor the specification developer approved and signed the DAR as required by the DAR to show the acceptance and distribution status of these 25 reworked devices or whether the specification developer later rejected and returned these reworked devices to your firm for repeat rework.

4. Failure to establish and maintain process control procedures rework, retesting, and revaluation of the nonconforming product after rework to ensure that the product meets its current approved specifications, as required by 21 C.F.R. § 820.90(b)(2). Specifically documents collected during the inspection revealed that your [(b)(4)] "Housing Unit Checklist" did not document or reference specific rework instructions for reworking and retesting the devices that failed their initial acceptance tests. For example, 25 malfunctioned device, that had diode assembly errors, 19 malfunctioned devices that had [(b)(4)], seals replaced, and 115 malfunctioned devices that had global board chips replaced.

5. Failure to establish and maintain process control procedures that describe any, process controls necessary to ensure conformance to specifications, as required by 21 C.F.R § 820.70(a). Your firm has not maintained complete instructions, standard operating procedures, and methods that define and control the manner of production. For example, your firm verbally stated to the investigator that the hand-held cryopens were tested [(b)(4)] and must fall to a temperature below [(b)(4)]F, and between each test, the cryopens are [(b)(4)]. These specific test instructions were not documented.

6. Failure to establish and maintain complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the other requirements of 21 C.F.R § 820.198 are met. Specifically, documents collected during the inspection revealed that your firm had a complaint form but did not use it to document quality issues your firm received. In reviewing the six service request/return forms filled out by the specification developer and your firm, two complaints had not documented an investigation, evaluation, and corrective action; and four complaints had not documented an investigation why the power jacks were disconnected in the four devices.

Responding to This Warning Letter

You 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/or civil money penalties.

Also, 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, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) deviations are reasonably related will not be approved until the violations 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur overtime, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.



Reynaldo R. Rodriguez,
Dallas District Director