Drug factory · FDA FEI 1000158576

Novo Nordisk Pharmaceutical Industries, LP

3612 Powhatan Road, Clayton, NC, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Sep 2, 2009 inspection

• Control procedures to monitor and validate performance 21 CFR 211.110(a)
  Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
• Following/documenting laboratory controls 21 CFR 211.160(a)
  Established sampling plans are not documented at the time of performance.
• Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
  Test procedures relative to appropriate laboratory testing for sterility are not followed.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Training--operations, GMPs, written procedures 21 CFR 211.25(a)
  Employees are not given training in the particular operations they perform as part of their function.
• Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
  Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
• Product flow through building is inadequate 21 CFR 211.42(b)
  The flow of components and closures though the building is not designed to prevent contamination.
• Defined areas of adequate size for operations 21 CFR 211.42(c)
  The control systems necessary to prevent contamination or mix-ups are deficient.
• Equipment Design, Size and Location 21 CFR 211.63
  Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
• Representative Samples 21 CFR 211.84(b)
  Representative samples are not taken of each shipment of each lot of closures for testing or examination.
• Reports of Analysis (Components) 21 CFR 211.84(d)(2)
  Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
• Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
  An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.