| Public Health Service Food and Drug Administration |
| San Juan District Compliance Branch 466 Fernandez Juncos Avenue San Juan, PR 00901-3223 TEL (787) 474-9500 FAX (787) 729-6658 |
Department of Health and Human ServicesWARNING LETTER
11-SJN-WL-05
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
February 7, 2011
Mr. Jack Wisniewski, CEO
RD Medical Manufacturing Holding Company
1465 East Putnam Avenue
Suite 229
Greenwich, CT 06870
Dear Mr. Wisniewski:
During an inspection of your firm located at Parque Industrial Las Piedras, Carr.183 Km 21.6 Anibal Garcia Pena Ave., Las Piedras, Puerto Rico conducted from 10/06/10 through 11/18/10, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class I and Class II convenience kits and intravenous (IV) sets. 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 function of the body.
The inspection found 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 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 (C.F.R.), Part 820.
We received a written response signed by Ms. Bernice Pagan, Quality Manager, dated 12/13/10, concerning the observations noted on Form FDA 483, List of Inspectional Observations that was issued to your firm on 11/18/2010. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to fully review, evaluate, and investigate a complaint involving the possible failure of a device as required by 21 C.F.R. § 820. 198(c).
Specifically, your firm received a complaint from one of your distributors on 07/22/09 describing "Y-sites glue upside down" in code number (b)(4) lot LYE023. This code number corresponds to your device 84" Basic IV Administration Set, 15 drop Luer Activated Injection Site. Your complaint file has information which indicates that samples available at your firm of lot LYE023 were visually inspected and that you confirmed the defect in 2 units of product. One of your firm's officials indicated during the inspection that a total of 43 units of lot LYE023 were inspected but this information was not included in your complaint file. Further evaluation of your complaint file shows that this same distributor sent you several communications indicating that you had "repeated the mistake" on the most recent lot received, Lot LYG004, for which your distributor received a complaint because Y-sites were glued upside down. Your , distributor indicated that a sales representative confirmed that 130 units of Lot LYG004 had the defect.
We found objectionable that your distributor indicated that they received a complaint for Lot LYG004 for the same defect and you did not extend your investigation to evaluate this lot. You indicated during the inspection that you did not have units available at your site to conduct an inspection. Further communication from your distributor indicates that they did a "spot check" on units from Lot LYG004 and no defective product was found.
You also mentioned that your distributor might have mistakenly reported lot LYG004 instead of Lot LYE023 as the defective lot. Nevertheless, information included in your complaint file indicates that a distributor's sales representative confirmed the defect in Lot# LYG004.
Your investigation concluded that the assignable cause for the incorrect assembly was attributed to human error. However, you failed to provide documentation showing that your firm evaluated the adequacy of your process controls for product code (b)(4) in ensuring the release and distribution of devices within specifications. You also failed to extend your investigation to other lots with the same product code to check for defects. Moreover, you did not provide documentation for an analysis of the risks associated with the reported defect and its effect on product in distribution.
We evaluated your written response dated 12/12/2010 addressing this issue and we found it inadequate. You indicated that you will add an addendum to your complaint record indicating that a total of 43 units of Lot LYE023 were inspected but you did not include in your response evidence showing the inspection results of the 43 units. In addition, your response indicates that information recently provided by your distributor indicates that the complaint lot was Lot LYE023 and not Lot LYG004. Nevertheless, you failed to include evidence of this new information with your response to the Agency. You also failed to address why you did not extend your investigation to include Lot LYG004, when your distributor only conducted a spot check which was not documented and after having information that a sales representative found the defect in this lot.
Regarding the distribution of Lot LYE023, you indicated that you have requested information from your distributor concerning product at the distribution level and actions taken concerning lot LYE023. Please clarify in your response to this letter if you intend to take a field action towards distributed lot LYE023. In addition, please provide evidence to show that Lot LYG004 does not have the same type of defect as the one found in Lot LYE023. Even though you indicated in your response that you have not received additional complaints for Lot LYE023 and Lot LYG004, if you are aware that your product is defective your firm shall take actions to correct the situation and prevent from recurrence.
In addition, your response indicates that performance tests conducted to samples of product code (b)(4) with the Y-site glued upside down confirmed that the product functionality is not affected by this defect. This conclusion differs from your Product Failure Mode Effect and Criticality Analysis (FMEA) which establishes that an incorrect assembly orientation in the Luer Activated Injection site makes the device unusable. In your response to this letter, please clarify this discrepancy and provide scientific data to support your conclusions.
2. Failure to have documentation showing that all your personnel are trained to adequately performed their assigned responsibilities, as required by 21 C.P.R. § 820.25(b).
Specifically you failed to provide documentation showing that the operators performing the (b)(4) technique and the (b)(4) have been certified to perform function. At east 2 investigations conducted in 2009 and 2010 identified as root causes for product's failures inadequate operators techniques associated to the techniques mentioned above.
We found your response to this deficiency inadequate. You indicated that you have training records documenting the training of your personnel in specific functions and general functions. Nevertheless, you failed to include evidence in your written response to show that your operators have been trained in the techniques described above. You also indicated that your training procedure will be revised to include a certification program as part of your training requirements. Your target completion date is the second quarter of 2011. Please indicate which interim measures you have taken to ensure that your operators are adequately trained to perform the (b)(4) technique and the (b)(4).The release for distribution of several of your products depends in part on the operator's ability to adequately perform these tasks.
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 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.
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 bring your products into compliance.
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 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: Maridalia Torres, District Director. If you have any questions about the content of this letter please contact: Margarita Santiago, Compliance Officer, at 787-474-4789.
Sincerely,
/s/
Maridalia Torres
District Director
San Juan District
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