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

Want to learn more about this site’s inspection history?  Log in to your Redica Systems account today. Not a customer?  Try out Redica Systems for free.

Get Started with Redica for Free
Redica Systems Enforcement Analytics

Get Full Access to Redica Enforcement Analytics

Enter your email address and someone will contact you shortly to answer all of your questions and get you started.

Quality Management Systems for Small Pharma and Biotech Firms

Webinar: QMS for Small Pharma and Biotech Firms

Presented on Tuesday, March 30, 2021
by Fenton Fong, Founder, Managing Director, & Principal at xCellarate

Download the slide deck and video of this informative 1-hour webinar on the common challenges small pharma firms face when developing a QMS.

What you will learn:

  • Common challenges small pharma firms face when developing a QMS
  • Recent enforcement trends involving the Quality Unit
  • Impact of the COVID-19 pandemic

Download the Special Report


In this summary we identify:

GMP data from FY2017 to FY2020 for the Asia-Pacific region

Top 3 GMP primary and secondary citations

Top 3 483 observations

Download the Special Report

An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

In this summary we identify:

  • Data from 2019 UK MHRA Inspections
  • Trends from 2015, 2016, 2018, and 2019 inspections
  • Conclusions drawn from an analysis of drug inspection data

Experience the Power of Redica Systems

Redica Pro Free

Sign up for your FREE account today and get instant access to:

SEARCH Find the inspection records you want by inspector’s name, company name, site, city, country, etc.

WARNING LETTERS Easily search the largest database of FDA Warning Letters by date, company, FDA office, or subject

SITES Quickly assess inspection records including dates and inspectors across all of your sites

INSPECTIONS Complete list of FDA inspections by date, company, category, and country

Get Complete Access to the Redica Systems Platform

Please submit your email address and one of our team members will contact you shortly to answer all of your questions and get you started with the new Enforcement Analytics platform.

Discover the power of the most comprehensive database of 483s in existence.

Our database of over 20,000 483s is retyped and tagged, making it easy to create an Observation Report in seconds.

Eliminate days of work and get your FREE personalized 483 Observation Report.