Inspections, Compliance, Enforcement, and Criminal Investigations
LGS Technologies, LP 29-Aug-06
Department of Health and Human Services
Public Health Service
August 29, 2006
RETURNED RECEIPT REQUESTED
Mr. Mark Milewski, President
LGS Technologies, LP
2950 W. Wintergreen Road
Lancaster, TX 75134-1840
Dear Mr. Milewski:
During an inspection of your firm located in Lancaster, Texas, on July 12 to 20, 2006, an investigator from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures the [redacted] Cooler-Heaters. These products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), 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 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, their manufacturing, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation for medical devices found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to,the following:
1. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria prior to releasing the devices for distribution, as required by 21 C.F.R. § 820.80(d), and failure to adequately document acceptance activities, as required by 21 C.F.R. § 820.80(e). [FDA-483 Item 1].
For example, your firm failed to follow the required burn-in (break-in) time and temperature set points for the [redacted] cooler Heater devices in order to ensure correct device operations and detect premature device failures during the break-in period of the devices. Fifteen (15) of the seventeen (17) inspection forms documented that the devices did not have the burn-in time of at least [redacted] as required by your firm's "Next to Last unit Test with [redacted]". Additionally, none of the seventeen (17) inspection forms documented that your firm actual incremented the temperature set points from [redacted] C to [redacted] C every [redacted] during the break-in period.
2. Failure to establish and maintain adequate production and process controls that include documented instructions, standard operating procedures (SOP), and methods that define and control the manner of production, as required by 21 C.F.R.§ 820.70(a)(1). [FDA-483 Item 3].
For example, your firm does not have complete and approved instructions for the burn-in testing of the [redacted] Cooler-Heater devices. The last step in your procedure entitled "Next to Last unit Test with [redacted] which is Step 16, states: "follow the next steps. . . ". Your firm failed to define and document what the next steps are.
3. Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, including verification or validation of such changes, as required by 21 C.F.R. § 820.70(b), and failure to promptly remove obsolete documents from all points of use, to approve changes to documents, and to maintain records of changes that include a description of the change, identification of affected documents, the signature of the individual approving the change, the approval date, and when the change becomes effective, as required by 21 C.F.R. § 820.40. [FDA-483 Items 3, 4, 5, 6, and 7].
a. Your firm changed the [redacted] Cooler-Heater device's internal timer setting in two instances. The reason for the changes, the review and approval for the changes, and the effective date of the changes were not documented.
b. Your firm failed to revise and finalize the three versions of the device assembly procedures to ensure that only one final approved procedure containing a correct and approved internal timer setting is used for the assembly and testing of the devices.
c. Your firm failed to conduct, document, and maintain the results of the verification testing of each change in the device's internal timer setting to determine whether or not each change affect the device's operations and performance specifications.
d. The changes in the device's internal timer setting may require the original review and approval by your specification developer, who is responsible for initiating the device design specifications and transmitting them to your firm for manufacturing. Your firm failed to maintain records of communication with the specification developer to document who initiated and authorized the changes, the signature of the approving individual(s), the approval date, and an effective date of each approved change.
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, including the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 C.F.R. § 820.90(a). [FDA-483 Item 8].
For example, your firm has not: (a) evaluated and documented the point in the manufacturing process and the reason that three specific device components (i.e., a pump, a printed circuit board, and a valve) were identified as "bad' on your firm's shelves; and (b) documented the status of their disposition.
5. 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 C.F.R. § 820.60. [FDA-483 Item 9].
For example, the device sub-assemblies (device chassis) were stored on a metal shelf without any identification as to whether their manufacturing status was in-process, awaiting inspection, accepted or rejected, or ready for use.
6. Failure to document personnel training to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25(b). [FDA-483 Item 10].
For example, your firm stated that three individual employees involved in the assembly of the [redacted] Cooler-Heater devices had been trained but that your firm could not provide any documentation of their training.
You should take prompt action to correct the violation addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration 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, premarket approval applications for Class III devices to which the Quality System regulation 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 violation(s), or Similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, 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, 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.
Finally, you should. know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Mictbel A. Chappell
Dallas District Director