FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Shredded Documents, Dirty Equipment Net Hetero Labs a Form 483

Feb. 1, 2017

Hetero Labs has been handed a Form 483 after an inspection revealed employees shredding documents, in addition to sanitation and GMP issues. Investigators listed eight observations after inspecting the firm’s India plant in December 2016.

FDA investigators reviewed the facility’s own closed-circuit TV feed and identified employees bringing in a shredder into a room labeled “documents storage area,” four days before the agency’s inspection.

The recording showed extensive shredding of documents — and new documents being signed by the quality assurance manager in the middle of the night. Investigators believe the documents were batch manufacturing records, a GMP report, and a printout indicating an “abort” event in testing.

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