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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Boukhari Prince Medical BPM sa 8/3/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, .MD 20993

AUG 3, 2012

WARNING LETTER 

 
VIA UNITED PARCEL SERVICE
 
Mr. Haitham Boukhari
President/Co-owner
Boukhari Prince Medical BPM sa
Parc d’Activites Economiques de Bizerte – 7000
Bizerte, Tunisia

Dear Mr. Boukhari:
 
During an inspection of your firm located in Bizerte, Tunisia, on March 29-31, 2012, and April 2, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Urodynamic Catheters and Regulator Administration 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 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 manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 

We received a response from you dated April 23, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm.  We address this response below, in relation to each of the noted violations.  These violations include, but are not limited to, the following:

1. Failure to adequately ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).  For example, your firm has (b)(4). Your firm failed to document a validation plan for the (b)(4). You informed the investigator that your firm did not have a general validation plan or procedure and that (b)(4).

The adequacy of your firm’s response cannot be determined at this time. Your firm proposes providing a written procedure for process validation and a validation plan for (b)(4). However, your firm did not submit documentation or evidence of implementation of the changes or employee training for the new procedure to the FDA. Additionally, your firm did not provide any specific plan or evidence addressing global systemic corrective actions for retrospectively validating all of the (b)(4) where the results cannot be fully verified.

2.  Failure to establish and maintain adequate requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, your firm did not follow the (b)(4) procedure. The investigator reviewed  (b)(4) supplier records and found that (b)(4) of the suppliers were not evaluated or included on your firm’s approved list of suppliers.

The adequacy of your firm’s response cannot be determined at this time. Your firm proposes updating procedure “PROC018” to include that the (b)(4).  However, your firm did not submit documentation or evidence of implementation of the changes or employee training for the updated procedure to the FDA.

3.  Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).  For example:

A.  Your firm's complaint procedure, “Non Compliance Treatment Corrective and Preventative Action (Traitement des Non Conformities Actions Corrective et Preventivies),” Proc.16, Revs. 3-8, dated April 10, 2009 - January 16, 2012, does not adequately define a complaint or the process for handling complaints.  Device complaints are comingled and not identified from non-conformances occurring prior to release to distribution; and,  

B. The procedure does not require that complaint investigations include:

1. Evaluation to determine whether the complaint represents an event that is required to be reported to the FDA;
2. The date the complaint was received; and
3. The name, address, and phone number of the complainant.

Of the 11 complaints reviewed, none were evaluated for MDR reportability, the date received was not clearly documented, and the address and phone number of the complainant was not always included.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm plans to make changes in “PROC016: (Traitement des Non Conformities Actions Corrective et Preventivies)” to address the above deficiencies. However, no documentation or evidence of implementation for the changes or employee training for the revised procedure was submitted to the FDA for review.  Your firm did not submit proof of reviewing all investigational records to determine if the required information was documented.  Additionally, your firm did not provide any specific plan or evidence addressing global systemic corrective actions for receiving, reviewing, and evaluating past complaints.

4. Failure to establish and maintain adequate procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). For example,  (b)(4)

We reviewed your firm’s response and conclude that it is inadequate. Your firm proposes reviewing PROC 009 and changing the name to (b)(4). However, your firm did not submit documentation or evidence of implementation of the changes or employee training for the revised procedure to the FDA.  Although your firm submitted a picture of the finished product with a revised label, the firm did not provide the revised label translated to English. Your firm also failed to address the (b)(4). Additionally, your firm did not provide any specific plan or evidence addressing global systemic corrective actions for the lack of storage to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution of current devices, and to ensure that no obsolete, rejected, or deteriorated product is used or distributed.

5. Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use based on a valid statistical rationale and to ensure that, when changes occur, the sampling plans are reviewed, as required by 21 CFR 820.250(b).  For example, your firm’s testing of incoming components is not based on a valid statistical rationale. The “Purchasing, Receiving of Raw Materials” procedure (“Achats Et Reception Controle des Matieres Premieres Approvisionnees”) PROC 17, dated January 1, 2012, has no statistical rationale for the sampling plan of (b)(4) of incoming components.

The adequacy of your firm’s response cannot be determined at this time. Although your firm proposed adding the valid statistical rationale of the sampling performed to PROC 17, it did not submit documentation or evidence of implementation of the changes or employee training for the revised procedure to the FDA.

6. Failure to establish and maintain adequate procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR), as required by 21 CFR 820.184.  For example, the DHRs do not include or refer to the quantity manufactured, the quantity released for distribution, or the primary identification label and labeling used for each production unit as evidenced on lots 211933, 220322, and 213443 of Urodynamic Catheters CH6-02 voies (cat # 206).

The adequacy of your firm’s response cannot be determined at this time. Your firm plans to correct deficiencies, but did not submit documentation or evidence of implementation of the changes or employee training for the revised procedure to the FDA.  Additionally, the firm did not provide any specific plan or provide evidence addressing global systemic corrective actions for updating the DHR.

7.  Failure to maintain adequate DMRs and to ensure that each DMR is prepared and approved in accordance with section 820.40, as required by 21 CFR 820.181.  For example:

A. All device specifications for the clear urodynamic protective tubing and the urodynamic catheter were not included; and

B. All packaging and labeling specifications were not included. (b)(4)

The adequacy of your firm’s response cannot be determined at this time. Your firm reports adding the reference of the transparent protector and specifications of all labels used for product form (BOM) PROC 003/M and document “Fiche  Produit.”  Your firm also reports adding the drawing of the protector.  However, the drawing was not submitted to the FDA for review. Your firm did not provide the revised procedure translated to English and did not provide any specific plan or evidence addressing global systemic corrective actions for updating the DMR. 

Our inspection also revealed that your firm’s Urodynamic Catheters and Regulator Administration Sets devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following:
 
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.  For example, your firm failed to develop, maintain, and implement written MDR procedures.  Upon request by the FDA investigator, you stated that your firm does not have procedures for MDR reporting and that you were not aware that the FDA had a requirement for reporting adverse events.

We reviewed your firm’s response and conclude it is not adequate. Your firm proposes to prepare an amendment of the contract for its clients in order to add a new article about the necessity to inform (b)(4) about reportable adverse events and your firm’s responsibility to inform the client in case of an MDR. Your firm failed to submit written MDR procedures or a date that FDA could expect to receive the new procedure.  Additionally, your firm did not inform the FDA of any specific plan or provide evidence addressing global systemic corrective actions for retrospectively reviewing MDRs.

A follow up inspection will be required to assure that corrections and/or corrective actions are adequate. 
 
U.S. federal agencies may be advised of the issuance of 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective action (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. 

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS number 321958 when replying.  If you have any questions about the contents of this letter, please contact: Debra E. Demeritt at
301-796-5770. 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. 

Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.  

Sincerely yours,

/S/                                               
                                                                
Steven D. Silverman 
Director
Office of Compliance
Center for Devices and 
Radiological Health