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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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AM2 PAT, Inc 11-Aug-05

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

Public Health Service
Food and Drug Administration


Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30304

August 11, 2005


Dushyant M. Patel, President
AM2 PAT, Inc.
(dba) Salient Health Care Technology
9400 Ransdell Road, Suite 10
Raleigh, North Carolina 27603


Dear Mr. Patel:

During an inspection conducted at your establishment located at 9400 Ransdell Road in Raleigh, North Carolina on June 2-17, 2005, an investigator of the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of prefilled syringes for "intravenous catheter flushes. These syringes contain sodium chloride solution or heparin mixed in a saline solution. 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 investigator documented several significant violations of the Quality System Regulation (QSR), Title 21, Code of Federal Regulations (21 CFR), Part 820. These violations cause your devices to be 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, pacldng, storage or installation, are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the QSR for medical devices.

Quality System Regulation

The investigator observed a number of significant QSR violations including, but not limited to, the following:

1. Your firm failed to validate critical processes with a high degree of assurance or approve these processes according to established procedures, where the results of the process cannot be fu11y verified by subsequent inspection and test, as required by 21 CFR 820.75(a) [FDA 483, Items 1 & 2]. You have also failed to fully document process validation activities and results. You are utilizing an unvalidated automatic filling machine to fill syringes. An appropriate installation and operation qualification could not be performed as there are no manufacturing or operating instructions available for the equipment. You failed to follow the draft validation procedure dated 5128105 for the media fill performed on 5127. Only one media fill of [redacted] syringes was conducted although the procedure on file called for [redacted] such runs. The filling machine had already been used for production of syringes on two days.

The available validation information for the [redacted] machine was also seriously deficient. There was no indication of sample sizes utilized and no actual test results available for the packaging runs. There was no established acceptance criteria and no established processing parameters. The limited information available from the previous owner lacked any mention of significant equipment and operations such as printer, counter, vacuum, line speed, and thermocouples.

2. Your firm failed to establish and maintain procedures to adequately control environmental eonditions which could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c) [FDA 483, Item 4]. The Class [redacted] manufacturing area has not been qualified every [redacted] months as required by your Airborne Particulate Monitoring procedure. It has only been qualified annually. In addition, the last qualification that was done was not performed under dynamic conditions. You have failed to establish format parameters for temperature, humidity, and pressure . A review of Filling Room temperature records revealed several instances where the temperature range limits (on the form) were exceeded. The cleaning log indicating the daily cleaning of the Clean Room is filled out once a month by the Clean Room Supervisor instead of by the employee that conducted the cleaning on the date it was actually performed.

3. Your firm failed to establish and maintain procedures for finished device acceptance that will ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d) [FDA 483, Item 5]. Manufacturing employees are expected to visually inspect filled syringes for foreign material; print on the syringe barrel, wrapper, cap; and examine the packaging seals. These employees are also responsible for other tasks on the packaging line such as adding syringes to the line and maintaining a constant flow of labeled syringes. The line speed is estimated to be [redacted] syringes per minute. The line speed has never been validated however and the employees' ability to adequately detect these defects has never been established at this or any other speed.

4. Your firm failed to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b) [FDA 483, Item 10 & 12]. Incoming raw, materials are not inspected and tested as required by your Inspection and Test procedures. The number of samples tested is not documented and would not appear to follow the prescribed sampling plan. Incoming products and components are accepted without receiving and reviewing certificates of conformance as required by your procedures. You have also failed to establish and maintain procedures to ensure that all purchased product conforms to specified requirements, as required by 21 CFR 820.50. Although Supplier Evaluation Forms have been drafted, none of the procedures have been implemented. No evaluation or auditing of existing or new suppliers had been conducted for any of the significant suppliers of sterile components.

5. Your firm failed to establish complaint handling procedures sufficient to ensure that all complaints are documented and processed in a uniform and timely manner, as required by 21 CFR 820.198(a) [FDA 483, Item 3]. You have failed to follow the complaint handling procedures you established when complaints have been received at your firm. You have failed to initiate a Returned Goods Authorization form when a complaint is received. Our investigator could not determine if any effort was made to obtain product from the complainant for analysis. Complaint investigations did not include any discussion as to why syringes were not obtained for analysis. Complaint numbers are not assigned as per procedure. Your complaints were also not evaluated tu determine if they should be filed as a Medical Device Report under 21 CFR 803, as required by 21 CFR 820.198(d).

6. Your firm failed to follow established procedures for quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22 [FDA 483, Item 6]. The 2004 audit schedule failed to include critical subsystems such as Corrective and Preventive Action (CAPA), non-conforming product, and quality audits . These subsystems have also not been audited this year.

7. Your firm failed to establish and implement effective document control procedures, as required-by 21 CFR 820.40 [FDA 483, Item Il]. Many of the uality control procedures on file were implemented by the firm's former owners [redacted] and may no longer be applicable to actual operations at your facility. Many of the procedures still bear the name of [redacted]. Some of these procedures on file were identified as obsolete during the inspection such as those describing osmolality and particulate matter analysis. The procedures need to be reviewed and updated to include only those that are representative of current practice.

8. Your firm failed to maintain documentation of the training given to your personnel to ensure that they can adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b) [FDA 483, Item 13]. You have failed to follow your training procedures, Your Personnel Quality System Training procedure states that all employees involved in manufacturing, quality assurance, quality control, and documentation are required to attend GUT - Quality System Regulation training sessions. No documentation was available for any of this GMP/QSR training. Evidence of improperly trained personnel included an employee chewing gum while filling syringes and an employee improperly gowning during sterility testing.

9. Your firm failed to provide sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by the regulations are correctly performed, as required by 21 CFh 820.25(a) [FDA 483, Item 7]. One individual is primarily responsible for reviewing the quality data, performance of all tests, and conducting the filling revalidations, in addition to other quality related responsibilities . One of your key quality control positions has remained vacant for several months. This has resulted in some of the quality records not being properly reviewed such as the cleaning records for the [redacted] heat sealer, and labeler.

Response to FDA 483.

We acknowledge both your verbal commitment to correct the observed deficiencies and the receipt of your letter dated July 12, 2005. Although your July 12, 2005 response appears to adequately address some of FDA's inspectional observations, the response to several FDA observations appears to be inadequate, and some corrective actions will need to be verified during a subsequent inspection of your facility. FDA will include your July 12, 2005 response in your official file and will review it in conjunction with your response to this letter. Following your response to this Warning Letter, FDA will promptly provide a detailed evaluation of your responses.

Responding to this Warning letter

This letter is not intended to be an all inclusive list of the deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The QSR deviations, described above, were included on the Inspectional Observations (FDA 483) which was issued to and discussed with you, at the conclusion of the inspection. The specific violations noted in this letter and -in the FDA 483 may be symptomatic of serious underlying problems in your firm's quality assurance system. You are responsible for investigating and determining the causes of the violations identified by the FDA. You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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 premarket submissions for Class III devices to which QSR deficiencies are reasonably related will be cleared 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 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 fiwnes 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 Philip S. Campbell, Compliance Officer, at the address noted in the letterhead . If you have any questions about this letter, you can contact Mr. Campbell at (404) 253-1280.

Sincerely yours,


Mary H. Woleske, Director
Atlanta District