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# Lupin Gets Warning Letter After Inspection
- URL: https://www.fdaweb.com/lupin-gets-warning-letter-after-inspection/
- Published: 2022-10-03T12:00:00.000Z
- Updated: 2026-09-14T18:01:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152873

FDA has issued India-based drug maker Lupin a Warning Letter after inspecting its Tarapur, Maharashtra facility 3/22 to 4/4\. The company says it does not believe that the Letter will have an impact on product supplies. “We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest,” it says.

Lupin has been in FDA regulatory hot water the past few years. Earlier this summer, Lupin hired recently retired FDA New Jersey District director **Diana Amador-Toro** as the company’s senior vice president of global compliance. Based in Somerset, NJ, Amador-Toro presumably will be helping to correct ongoing violations at Lupin’s New Jersey manufacturing facility.

The plant was hit with a Warning Letter a year ago over GMP violations that the agency said were similar to violations at other Lupin facilities. Specific violations were:

- failing to establish and follow adequate written procedures for cleaning and maintenance of equipment;
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
- failing to establish and follow adequate written responsibilities and procedures applicable to the quality control unit.

A March inspection at the plant this year resulted in a 13-item FDA [Form-483](https://www.fda.gov/media/158445/download?ref=fdaweb.com) that cited the firm’s quality system, which it said was a repeat finding, for failing to thoroughly review any unexplained discrepancy in, or failure of, a batch or any of its components to meet any of its specifications. It also found the responsibilities and procedures for the quality control unit were not in writing and fully followed. And it said procedures describing the handling of all written and oral complaints regarding a drug product were not written and followed. Other repeat findings included:

- Employees lack the training required to perform their assigned functions.
- Written procedures are not established and followed for the cleaning and maintenance of equipment
- Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
- Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components conform to appropriate standards.

A [CNBC report](https://twitter.com/i/status/1532298062676127744?ref=fdaweb.com) says Amador-Toro’s global compliance functions will focus on training, internal audits and investigations.

Meanwhile, Lupin says it also just received from FDA an Establishment Inspection Report (EIR) for its Ankleshwar manufacturing facility in Gujarat, India. The agency conducted an inspection at the facility 8/16-19\. The release of the EIR signifies that no significant inspection findings were unresolved.