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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Vetoquinol N-A Inc. 23-Sep-02

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

Public Health Service
Food and Drug Administration

 

Center for Veterinary Medicine
Division of Compliance
7500 Standish Place
Rockville, MD 20855


September 23, 2002

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. N. Robichaud
General Manager
Vetoquinol N-A. Inc.
2000 Chemin Georges
Lavaltrie (Quebec)
Canada JOK 1HO

Dear Mr. Robichaud:

This letter is regarding the U.S. Food and Drug Administration (FDA or Agency) inspection of your J. Webster Laboratories Inc. veterinary pharmaceutical manufacturing facility in Princeville, Quebec, Canada conducted by CSO James A Liubicich from December 3-6, 2001. As part of the inspection, a preapproval inspection was conducted covering your product, Superiorbute Powder, ANADA 200-333. The inspection revealed significant deviations from the Good Manufacturing Practices (GMP) under Part 211 of Title 21 of the Code of Federal Regulations (CFR) 21 CFR Part 211. At the conclusion of the inspection, a fifteen item FDA-483, List of Inspectional Observations, was issued to Mr. Alan Hubert, Director of Quality Assurance. These GMP deviations cause your firm's approved veterinary pharmaceutical products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). 21 USC § 351 (a)(2)(B). Section 501 (a)(2)(B) of the Act requires that all drugs be manufactured, processed, packed and held according to current good manufacturing practice. No distinction is made between human and veterinary drugs and the failure of either to comply with GMP constitutes a failure to comply with the requirements of the Act.

We have reviewed your firm's December 21, 2001 response to the FDA-483 observations signed by Dr. Gadbois of your firm. We find that the response lacks sufficient detail, explanation, documentation, or substantive corrective action plans to adequately address the deviations noted during the December 2001 inspection of your manufacturing facility in Princeville, Quebec, Canada.

We acknowledge that your firm has made some changes and corrections in response to Agency findings and requests. However, we have found that while some individual GMP deficiencies may have been corrected, your firm has failed to institute sufficient corrections to achieve comprehensive GMP compliance.

Our concerns include, but are not limited to, the following:

A. Any unexplained discrepancy or the failure of a batch to meet any specifications shall be thoroughly investigated, whether or not the batch has already been distributed. A written record of the investigation shall be made and shall include the conclusions and followup.

In the response to the FDA-483 items, the firm concurs with the investigator's findings that thorough investigations were not done. A review of all prior and present out-of specification findings needs to be performed and corrective actions documented. These type of discrepancies must be investigated and a detailed record submitted. Additionally, the proposed draft SOP for out-of-specification results was not submitted for evaluation as to it's adequacy with the requirement.

B. Written procedures shall be established and followed prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics.

The firm's response acknowledges that lots of product were reprocessed. The firm lacks a written procedure for reprocessing batches that failed specifications. If the firm intends to continue to reprocess batches of product, a finalized reprocessing procedure shall be implemented. The firm needs to submit a copy of the finalized procedure.

C. Written procedures shall be established and followed for cleaning and maintenance of equipment. A cleaning standard operating procedure must be established to demonstrate that the equipment used in the manufacturing of non-penicillin products is free of penicillin contamination.

The December 21, 2001 response states the firm initiated a cleaning validation study but never completed the process. A finalized validation procedure shall be completed and implemented before commercial lots of product are entered into commerce. The response implies that there is scientific data to support the cleaning procedure but the final procedure was never finished or submitted.

D. There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

In the December 21, 2001 response to FDA-483 items # 5 & 7, the firm states that manufacturing validation protocols will be written. Validation of manufacturing processes is a requirement of the current good manufacturing practice regulations. Validation is based on the documented successful evaluation of multiple full scale batches. The firm needs to submit a copy of the finalized protocol and data supporting the satisfactory completion of the validation.

The GMP deviations identified above or on the FD-483 issued to your firm at the close of the recent inspection are not to be considered an all inclusive list of the deficiencies at your facility. FDA inspections are audits and are not intended to determine or disclose all problems or deviations that exist at a firm. We recommend that you continually evaluate your facility on an overall basis to determine GMP compliance.

Until such time as FDA can confirm compliance with 21 CFR Part 211 Current Good Manufacturing Practices and that correction of the deficiencies noted above have been achieved, we will be recommending disapproval of any NADA/ANADA applications for your firm. Further, if corrections are not made, we will recommend that your firm's products be placed on import alert and be denied entry into the United States. Articles can be refused admission pursuant to Section 801(a)(3) of the Act, 21 USC § 381 (a)(3), in that the methods and controls used in their manufacture do not appear to conform to current good manufacturing practice within the meaning of Section 501 (a)(2)(B) of the Act.

Please notify this office in writing of the specific steps that your firm has taken to correct these violations, including documentation of each step that you have taken to prevent their recurrence. Such documentation should include not only statements of what actions you have taken but should also include copies of any protocols, reports, procedures, records and documentation referenced as well as copies of any raw data generated. You should provide specific and detailed time frames for any changes or corrections to be made that have not yet been accomplished.

We wish to point out that it is not the responsibility of the U.S. Food and Drug Administration or the Center for Veterinary Medicine to translate documents. Therefore, it will be necessary that you submit not only the original documents but an adequate and accurate translation of each document into the English language. Failure to submit such translations will prevent us from reviewing whatever response or submission you make.

If you have any questions regarding this letter, please contact Compliance Officer William Bargo at 301-827-6605. His fax number is (301) 594-1812.

You may address future compliance-related correspondence to:

U.S. Food & Drug Administration
Center for Veterinary Medicine
Division of Compliance (HFV-230)
7500 Standish Place
Rockville, MD 20855

Remember to include your Central File Number (9710295) in all your correspondence.

Sincerely,


/S/

Gloria J. Dunnavan
Director
Division of Compliance (HFV-230)
Office of Surveillance and Compliance
Center for Veterinary Medicine

CC:
Mr. Jacques Cliche
Production Director

J. Webster Laboratories
700, rue St-Henri
Princeville, Quebec
Canada G6L 4X1