Novo Nordisk — FDA 483 Findings

ubstance manufacturing and processing unit operations that have been observed to be performed forr> (.iJ)­ (u, ,.., IDS at the Novo Nordisk NS drug substance manufacturing facility (FEI: 3002807751) are not included in tiiefb) <4> ~ubmission to the Agency for review.

Master production ~d control records lack complete manufacturing and control instructions.

The validation of thefb> (.J) IDS manufacturing process, including a full description ofthe validation data for critical process parameters and in-process controls in support of routine production have not been appropriately 4 documented in the lb) < >

Written procedures used in the manufacture, processing, or packing that are designed to assure identity, strength, quality, and purity ofthe drug substance are inadequate.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Th routine amole volume that is used to test for appropriate standards of quality and purity ofthe ~bf(.iJ~ ater for b) (.iJ) --~ - losmanufacturing is insufficient to be representative ofthe capacity ofthe water systemi b (.iJ>7 and(b) (4) ~

Ins_ufficient information has been provided to demonstrate that thef6}l.i1)7water an/fC.iJJ ater used for 4 {b) <> !drug substance (DS) purification is adequately controlled for total microbial counts and objectionable organisms in water systemsrfC.iJ) I

Laboratory controls do not include the establishment ofscientifically sound and appropriate sampling plans designed to assure that Qroduction cultures conform to appropriate standards of identity, strength, quality, and purity.