FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a. LUPIN, located in Somerset, NJ.  The 22-day inspection of this drug product manufacturer ended on November 5, 2020, and resulted in a total of 13 multi-part observations over 38 pages.

This has been one of the few on-site inspections performed by the FDA during the COVID-19 health emergency.  The inspection was conducted by four investigators and the site appears to manufacture solid oral dosage forms, not aseptically manufactured products. The FDA inspection database does not have this inspection listed and classified yet though it is provided in the Office of Regulatory Affairs Reading Room.  

Personally, based on the length of the form 483 and type of observations this will likely be an OIA classification and likely be followed by a warning letter.  We will watch and report if that happens.  

Anyway, the 483 observations include but are not limited to:

• Non-dedicated equipment used for commercial products was labeled as  “cleaned” status.  White residue was identified in several locations along with damage to the equipment.  FDA is clearly trying to make a point about the depth and seriousness of the problem. 
• Investigations into an OOS event at a contract laboratory was not initiated until approximately one year later.  The investigation was incomplete. Other examples of inadequate investigations are provided.
• The stability program is not followed and most of the batches are within expiry and distributed.
• Accuracy and sensitivity of test methods are not established.
• Quality Unit does not have nor executes appropriate responsibilities. 
• Procedures are not established and followed for cleaning and maintenance of equipment.
• Product transfers to another building, and subsequent validation is inadequate.
• Buildings are not maintained in a good state of repair.
• Areas are not adequate to prevent contamination of other processing areas by potent drugs.
• Appropriate controls are not exercised over computers.
• Annual product review SOP is not followed, and FDA provides an extensive list of problematic reviews.
• And last but not least, employees lack adequate training.

Lupin, the parent company based in Mumbai, India, is no stranger to enforcement actions with an API site that received a warning letter in 2019 and a finished dosage form site that received one in 2017. 

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