Warning Letters: DanChem Technologies and Medsep

March 10, 2005
Pharmaceutical Technology Editors
Pharmaceutical Technology

Warning Letters: DanChem Technologies & Medsep


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

On March 3, FDA's Baltimore (MD) District Office sent a three-page

letter toDanChem

, an active-pharmaceutical-ingredient maker. The lettercited "physical filth" contamination found by a customer in severallots of calcium polycarbophil. The warning also cited "significantviolations of current good manufacturing practice" found during agencyinspections last fall, including:

  • blending out-of-specification calcium polycarbophil with in-specbatches to bring the combined batches within specification;

  • omitting ingredient names and weights from batch records;

  • maintaining "inaccurate" disposal records by labeling, disposingof, and recording debris-filled ontainers as "rejected API";

  • failure to review batch records that indicated that the amount ofmaterial produced exceeded the capacity of the processing equipment;and

  • failure to investigate foreign material found in manufacturingequipment.

On Feb. 15, the Los Angeles District Office (Irvine, CA) sent a letter toMedsep (a subsidiary of Pall Corp., East Hills, NY, www.pall.com), dealing mainlywith procedural and record-keeping shortcomings in the manufacture ofbacterial detection devices used with oxygen analyzers. The inspectiondid note, however, that "Anticoagulant Citrate Phospahate DoubleDextrose Solution with AS-3 Nuhicel Additive System" (used in bloodcollection bags manufactured at the same facility) are regulated underdrug CGMPs, and cited inadequacies in the batch production and controlrecords.

–Doug McCormick