WOCKHARDT LIMITED, AURANGABAD, INDIA RECEIVES WARNING LETTER (7/18/13)

FIRM IS CITED FOR WITHOLDING TRUTHFUL INFORMATION AND DELAYING AND LIMITING THE INSPECTION

Wockhardt Ltd was recently audited by the FDA during the timeframe of March 18 – 22, 2013 at their Biotech Park, Aurangabad, India.  During this audit the FDA documented that Wockhardt Ltd was found to have withheld truthful information, and delayed and limited the inspection.  The delay and limiting of the inspection extended to a refusal to permit entry or inspection.

Ironically, the FDA recently released a DRAFT Guidance for Industry (see Blog: FDA’s GUIDANCE FOR INDUSTRY PROVIDES CIRCUMSTANCES THAT CONSTITUTE DELAYING, DENYING, LIMITING OR REFUSING A DRUG INSPECTION, 7/18/13) that discusses various tactics that Industry uses to impede FDA audits at their facilities.  This particular Warning Letter serves as a “poster child” for this DRAFT Guidance.  I encourage you to read this DRAFT along with the Warning Letter to determine if your firm is unknowingly performing any of these evasive actions.

As a result of this inspection, the FDA highly recommended that the Company hire a third party auditor with experience in detecting data integrity problems and to assist with the overall compliance with CGMP.  The FDA specifically listed areas for which a CGMP expert should participate as well as areas where a “data integrity consultant” would be helpful.

The CGMP expert should:

1. Perform a comprehensive inspection of the facilities, method, and controls used to manufacture drugs, and determine whether your facilities, method, and controls used to manufacture drugs are in compliance with CGMP requirements.
2. Evaluate whether your facilities have established and implemented a comprehensive written QA/QC program that is adequate to ensure continuous compliance with CGMPs requirements.
3. Evaluate whether your facilities have established and implemented an adequate stability program that accurately measures the stability characteristics of drug products.
4. Evaluate whether your firm has established and implemented a comprehensive written program to maintain production, control, and other records and to ensure the authenticity and reliability of all data reflected in those records.
5. Evaluate adequacy of data integrity training for all staff who perform CGMP activities. Identify gaps and implement ongoing training modules on the responsibility of all staff to assure authentic records. This training should also instruct your firm’s managers in detection of data integrity and manipulation practices. At minimum, staff from development, quality, operations, and regulatory affairs should be trained.

The data integrity consultant should:

1. Identify any historical period(s) during which inaccurate data occurred at your facilities.
2. Identify and interview your current employees who were employed prior to, during, or immediately after the relevant period to identify activities, systems, procedures, and management behaviors that may have resulted in or contributed to inaccurate data reporting.
3. Identify former employees who departed prior to, during, or after the relevant period and make diligent efforts to interview them to determine whether they possess any relevant information regarding any inaccurate data reporting.
4. Determine whether other evidence supports the information gathered during the interviews, and determine whether additional facilities were involved in or affected by inaccurate data reporting.
5. Use organizational charts and SOPs to identify the specific managers in place when the inaccurate data reporting was occurring and determine the extent of top and middle management involvement in or awareness of data manipulation.
6. Determine whether any individual managers identified in item (5) of this subparagraph are still in a position to influence data integrity with respect to CGMP requirements or the submission of applications; and establishing procedures to expand the internal review to any other facilities determine to be involved in or affected by the inaccurate data reporting.

The FDA has advised the Company that a “failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Wockhardt Limited located at Biotech Park,…Aurangabad, India.”