Warning Letters: DanChem Technologies and Medsep

Mar 10, 2005
By Pharmaceutical Technology Editors
Warning Letters: DanChem Technologies and Medsep

The US Food and Drug Administration this week released drug-product warning letters sent to DanChem Technologies (Danville, VA, www.danchem.com) and Medsep Corp. (Covina, CA).

On March 3, FDA's Baltimore (MD) District Office sent a three-page letter to DanChem, an active-pharmaceutical-ingredient maker. The letter cited "physical filth" contamination found by a customer in several lots of calcium polycarbophil. The warning also cited "significant violations of current good manufacturing practice" found during agency inspections last fall, including:
  • blending out-of-specification calcium polycarbophil with in-spec batches to bring the combined batches within specification;
  • omitting ingredient names and weights from batch records;
  • maintaining "inaccurate" disposal records by labeling, disposing of, and recording debris-filled ontainers as "rejected API";
  • failure to review batch records that indicated that the amount of material produced exceeded the capacity of the processing equipment; and
  • failure to investigate foreign material found in manufacturing equipment.

On Feb. 15, the Los Angeles District Office (Irvine, CA) sent a letter to Medsep (a subsidiary of Pall Corp., East Hills, NY, www.pall.com), dealing mainly with procedural and record-keeping shortcomings in the manufacture of bacterial detection devices used with oxygen analyzers. The inspection did note, however, that "Anticoagulant Citrate Phospahate Double Dextrose Solution with AS-3 Nuhicel Additive System" (used in blood collection bags manufactured at the same facility) are regulated under drug CGMPs, and cited inadequacies in the batch production and control records.

–Doug McCormick