Inspections, Compliance, Enforcement, and Criminal Investigations
Precision Converters, Inc. 18-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Dallas District |
4040 North Central Expressway
Dallas, Texas 75204-3145
October 18, 2005
RETURNED RECEIPT REQUESTED
Mr. Roger A. Liebelt
President and Chief Executive Officer
Precision Converters, Inc. (dba PCI Technology)
8181 Eastpoint Drive, Ste 500
Dallas, Texas 75227
Dear Mr. Liebelt:
During an inspection of your establishment located at the above-referenced address, on August 15, 2005 through August 31, 2005, a United States Food and Drug Administration ~(FDA) investigator determined that. your firm manufactures the Anti-Fog with Pad Kit, a sterile single use lens cleaning and anti-fog accessory intended to maintain visualization during procedures when lens fogging may be a problem associated with such devices as endoscopes, laparoscopes, and arthroscopes, and wound care products. 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).
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)) because the methods used in, or the facilities or controls used for the manufacturing, processing, packing, storage, or holding 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.
At the close of the inspection, you were issued a List of Inspectional Observations, Form FDA-483, which identified a number of significant QS Regulation violations including, but not limited to, those described below.
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30 [FDA-483 Items 1, 2, 3, and 4]. For example:
a) Your firm's design plan was not reviewed and approved by those identified as responsible for drafting, approving, and implementing the design plan. See 21 CFR 820 .30(b).
b) Your firm has not established written procedures for adequately identifying, evaluating, and documenting design outputs which are considered work products or deliverable items of a design effort. For example, your firm failed to (1) identify the need to conduct a biocompatibility study or provide a scientific rationale as to why a biocompatibility study was not conducted prior to releasing the devices for commercial distribution; (2) document functional device testing methods in order to test the effectiveness of the device ; (3) describe and document the packaging material used to maintain sterility of the device, and test methods and acceptance criteria to test the five-year shelf life labeling
claim ; (4) document the design transfer process describing production process procedures (kit assembly procedures, pouch sealing procedures, and QA procedures) used by the contract manufacturers and sterilizer to manufacture and sterilize the device. See 21 CFR 820.30(d).
c) Your firm has not established written procedures for adequately identifying, evaluating, and documenting design input requirements to ensure that they are appropriate and address the intended use of the device, including the needs of the user and patient. For example, although the customer faxed you a copy of the proposed product label with a 5-year expiration date, your firm has not documented the 5-year expiration date as a formally approved design input requirement and evaluated it for adequacy. Further, neither your firm nor the customer has conducted and documented an objective analysis (e.g. shelf-life stability testing) of this design input requirement to verify if your packaged device
can maintain a 5-year shelf life . See 21 CFR 820.30(c).
d) Written procedures for conducting design verification or design validation were not established. See 21 CFR 820.30(f).
2. Failure to establish and maintain procedures for validating the device design to ensure that the device conforms to defined user needs and intended uses and shall include testing under actual or simulated use conditions and design risk analysis, where appropriate, as required by 21 CFR 820.30(g) [FDA-483 Items 5, 7, and 8]. For example:
a) Your firm has not conducted and documented a risk assessment for the device to determine all possible risks that can adversely affect the patient and the controls that can be implemented to reduce the probability and severity of risks.
b) Your firm has not tested or evaluated the anti-fog. solution to determine if it is capable of providing the anti-fog effect.
c) Your firm has not conducted a biocompatibility study to confirm if the antifog solution is biocompatible.
d) Your firm labels the finished device with the 5-year expiration date but did not conduct and document the results of a~shelf-life stability analysis of the finished device packaging material, anti-fog solution, and sponge) to substantiate this expiration date.
e) Your firm has not documented the effect of the [redaction] sterilization process on the anti-fog solution, sponge, and packaging material.
3. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device design development, as required by 21 CFR 820.30(e) [FDA-483 Item 6]. For example, your firm failed to follow its design review procedure in that your firm has not conducted and documented any formal design reviews.
4. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h) [FDA-483 Item 9]. For example, your firm failed to establish design transfer procedures for the [redaction] contract manufacturers, which perform the final assembly and packaging of the device kit and manufacture the antifog solution, to describe and ensure (a) how device design specifications are transmitted to the contract manufacturers, (b) how device design specifications are correctly translated into specific written production process specifications (e.g . environmental and contamination controls, device kit assembly instructions, formulation and mixing of the anti-fog solution, quality assurance inspection and tests, labeling and packaging, etc.) used at the contract manufacturers, and (c) how your firm verifies that the contract manufactured devices meet your firm's device design specifications.
5. Failure to adequately validate manufacturing processes with a high degree of assurance and approve them according to established procedures to ensure that product specifications can be consistently met, as required by 21 CFR 820.75(a) [FDA-483 Item 11). Two of the three packaging validations reviewed for two other medical devices your firm manufactures in-house had packaging [redaction] test results below their established specifications, and the validation results were accepted without investigating or justifying the out-of-specification results. For example, the packaging validation for Product #1042 had two of the [redaction] production runs, and Product #1040 had three of the [redaction] production runs with packaging [redaction] values below their minimum specification limits before and after the [redaction] sterilization.
6. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm has not established design transfer procedures defining specific requirements, including quality requirements, that must be met by your firrn's [redaction] contract manufacturers, particularly the contract manufacturer of the anti-fog solution. For example, your firm received complaints from a customer reporting a quality issue with the device (the anti-fog solution left a film on the lenses of the scopes), and subsequently two lots of the device kits (Lot #12590 and 12749) were returned to your firm for evaluation.
7. Failure to establish and maintain calibration procedures for manufacturing equipment to include specific directions and limits for accuracy and precision, as required by 21 CFR 820.72 b FDA-483 Item 10]. Your firm's calibration procedure for the [redaction] Model [redaction] package sealing machine, which is used to seal the pouches of the sterile wound care dressings, failed to include complete directions for calibratin the [redaction] temperature controller and thermocouples as specified in the [redaction] Instruction Manual. For example:
a) Your firm failed to calibrate .the full range of actual temperatures used during manufacturin The reading for the temperature thermocouples were observed at [redaction] degrees F, [redaction] degrees F, and [redaction] degrees F during actual packaging. Although these thermocouples were calibrated and qualified to read packaging temperatures higher than [redaction] F, they were not calibrated at the lower temperature ranges between [redaction] F and [redaction] F.
b) Your firm's calibration procedure did not specify or reference the warm up time before calibration and the requirement to reset the adjustment as specified in the- Instruction Manual.
We acknowledged receiving your firm's response, dated September 15, 2005, to the Form FDA-483, Inspectional Observations, issued to your firm at the conclusion of our inspection on August 31, 2005. Overall, your firm's response is incomplete.
Your firm responded that your firm failed to establish and implement adequate design control procedures (FDA-483 Items 1-9) for the sterile Anti-Fog with Pad Kit device because your firm believed that your firm acted as a contract manufacturer. Based on the information your firm provided to our investigator, it appears that [redaction] is merely a private label distributor of your firm's devices. You provided no evidence that [redaction] has established and maintained adequate procedures to control the design of this device. Because your firm actually developed the device design specifications, submitted a 510(k) for the Anti-Fog with Pad Kit and is expected to be the owner of this 510(k), performed manufacturin operations, and lacked a written regulatory agreement with [redaction] to define who is responsible for the design control aspect of this device, your firm is ultimately responsible for establishing and implementing complete and adequate device design control procedures.
Your firm further responded that your firm has ceased manufacturing and distributin the sub'ect device and will transfer the 510(k) application to your customer, [redaction] or will withdraw the 510(k) application. At the conclusion of our inspection, CDRH/ODE has not yet cleared your firm's 510(k) application for commercial distribution of the subject device due to a number of outstanding 510(k) deficiencies.
Your firm's response will remain incomplete until your firm:
a. provides FDA update reports of your firm's 510(k ) clearance status and a signed written regulatory agreement with [redaction] defining who will be responsible for the design controls of the Anti-Fog with Pad Kit and other specific quality system activities [redaction] will be performing.
b. Provides assurance that or any other customers who want to be a specification developer of the device will establish and maintain complete and adequate design control procedures.
c. provides update reports explaining the progress and the results of your firm's corrective actions correcting the remaining warning letter items and inspectional observations (FDA-483 Items 10 and 11) affecting other medical devices your firm is currently manufacturing.
We want to remind your firm that as a contract manufacturer, your firm is held accountable for:
a. executing the design transfer process from the specification developer to your firm. The design transfer process typically includes (1) translating the device design specifications into your firm's production specifications and procedures, including process validations ; and (2) notifying the specification developer of design transfer discrepancies for resolution.
b. validating packaging and sterilization processes for sterile devices, inprocess and finished device acceptance procedures, corrective and preventive action procedures to include monitoring and evaluating the ability of your firm's [redaction] subcontract manufacturers to meet your firm's specified requirements, including the quality requirements, and other
requirements of the Quality System Regulation.
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 fetter and in the Form FDA-483 may be symptomatic of other 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. Additionally, no applications for premarket approval to which the Quality System 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.
You should take prompt action to correct these violations. 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 penalties.
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-SW140, 4040 N Central Expressway, Suite 300, Dallas,
TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
Michael A. Chappell
Dallas District Director