FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Pan Drugs Production Manager Fabricated Signatures, FDA Says in Warning Letter

Sept. 13, 2016
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Pan Drugs, located in India, has received a warning letter due to a series of cGMP violations found during an inspection last year.

The inspection revealed a failure to establish an adequate quality control unit, and the production manager at the facility admitted that he falsified the signatures of other employees in the “Prepared By,” “Reviewed By,” “Approved By,” and “Authorized By” sections of various production records.

Additionally, Pan’s quality control unit failed to identify data integrity issues in 11 batch production records reviewed by FDA investigators and did not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured at the plant. The agency recommends a comprehensive investigation into the extent of inaccuracies in data records and reporting.

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