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CLOSEOUT LETTER

Medisca, Inc. May 24, 2016

Medisca, Inc. - Close Out Letter 5/24/16


Medisca, Inc.

  

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

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
Office Hours: 8:00 AM-4:30 PM
General Telephone Line: 718-340-7000
Consumer Complaint Line: 1-866-446-9055
Import Entry Status Desk: 718-662-5692

May 24, 2016

Mr. Antonio Dos Santos, President
Medisca Pharmaceutique, Inc.
6090 Henri-Bourassa West
Saint-Laurent, Quebec H4R3A6, Canada

Reference: Inspection Date(s): 04/04/2016 – 04/07/2016 and 02/17/2014-02/27/2014

Location: Medisca, Inc.
                661 State Route 3
                Plattsburgh, NY 12901-6531 US

Dear Mr. Antonio Dos Santos:

We are enclosing a copy of the establishment inspection reports (EIRs) for the inspections conducted at your premises on the referenced locate and date(s). When the Agency concludes that an inspection is "closed," under 21 C.F.R. 20.64(d)(3), it will release a copy of the EIR to the inspected establishment. This procedure is applicable to EIRs for inspections completed on or after April 1, 1997.

The Agency continually works to make its regulatory process and activities more transparent to the regulated industry. Releasing these EIRs to you is part of this effort. The copies being provided to you comprises the narrative portion of the report; it may reflect redactions made by the Agency in accordance with the Freedom of Information Act (FOIA) and 21 CFR Part 20. This, however, does not preclude you from requesting additional information under FOIA.

Additionally, we have completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-12 dated November 25, 2016. Based on our evaluation, it appears that you have addressed the violation contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

Although we are considering your inspections closed at this time, we have the following comment relative to your most recent inspection dated 04/04/2016 – 04/07/2016:

Observation #1 stated:

Written procedures were not followed to provide documentation, review and approval of changes of analytical method, equipment and verification of data integrity.

Your SOP PRO-QC-007, Change Control Procedure, ver. 01, was not followed to assure that input data in the form of new spectra used as reference standard during operation of Agilent Cary 630 FTIR, PBVP-001 and related electronic reference library database.

Specifically, your quality control unit failed to generate change control documentation, review and approve the addition of new in-house reference standard on 11/12/2014 for the purpose of identity testing of subsequent batches of Citrulline (L), product code 1186 (CA no. 372-7S-8).

Your firm used the spectra of Citrulline (L), lot no. 108470, as a reference standard for release of the following lots without a change control document and review of the accuracy and effectiveness of the change in your FTIR reference standard electronic library:

Table no. 9: Released Citrulline (L), lots after 11/12/2014

Lot no.
Release date 
 116202 11/19/2014
 119715 02/09/2015
 120159 03/11/2015
 122804 04/24/2015
 124401 05/28/2015
 126200 07/16/2015
 131219 01/27/2016

Your Quality Control Unit failed to document and to evaluate the impact of the change in the computer system, the performance characteristics and requirements for the validated analytical application of Agilent Cary 630 FTIR after addition of reference standard spectra on 11/12/2014 to the applicable software library of the FTIR.

Your April 20, 2016 response states you have initiated a change control document retrospectively to document and evaluate the impact of the change in the computer system, the performance characteristics and requirements for the validated analytical application of Agilent Cary 630 FTIR after addition of all reference standards to the FTIR library as of 04/06/2016. However, your response does not indicate when this correction will be completed or if it has been completed or how the adequacy of the correction will be assessed. Your response doesn’t include any documents that support the actions taken as part of the promised correction. Your successful implementation of your promised correction and its adequacy with respect to the cited violation will need to be assessed during a follow up inspection.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If there is any question about the released information or the contents of this letter, feel free to contact me at (518) 453-2314 x 1015 or alternatively write to: LCDR Catherine M. Beer, US FDA, One Winner's Circle, Suite 110, Albany NY 12205.

For more information on the U.S. FDA, please visit our website at www.fda.gov.


Sincerely,

/S/

LCDR Catherine M. Beer
Compliance Officer
New York District


Enclosure: Establishment Inspection Reports with addressee.


Cc (letter only): Lawrence Harney, General Manager US Operations
                         Medisca, Inc.
                         661 State Route 3
                         Plattsburgh, NY 12901-6531 US