U.S. FDA Flags 13 Lapses At Lupin’s Somerset Facility

The U.S. health regulator has flagged quality control and procedural lapses, as well as deficient equipment and laboratory standards at Lupin Ltd.’s facility at Somerset, New Jersey.

The U.S. Food and Drug Administration concluded an inspection—commenced on March 7 and concluded on March 30—at the company’s wholly owned subsidiary Novel Laboratories, Inc., according to Lupin’s March 31 exchange filing. The inspection of the formulations or final drugmaking unit closed with 13 observations, it said, without disclosing the details.

BloombergQuint obtained a copy of the observations from the FDA. Five of the 13 observations were a repeat of issues the regulator had flagged earlier.

Quality Observations

• Failure to review reasons for unexplained discrepancies and finding reasons why components of a batch failed to meet specifications. This was a repeat observation when even in case of product recalls, efforts to inspect the cause were not undertaken or were undertaken inadequately and with delay.

• Quality control procedures are not in writing and not fully followed. Investigations and audits are not adequately documented and proper procedure is not followed for issuance of documentation.

• Procedures for handling written and oral complaints are not followed and proper investigations not conducted.

• A repeat observation that states lack of training to employees engaged in manufacturing, processing and packaging of a drug product.

Facility And Equipment System

• Procedures for cleaning and maintenance of equipment, including materials used for cleaning and disassembly and reassembly are not adequately followed. No proper documentation was maintained and gap days were noticed.

• Repeat observation on how written procedures were not followed for cleaning and maintenance of equipment, including utensils used in manufacturing, processing, packing and holding of drug product.

• Equipments used through the manufacturing process up to holding of drugs was not of appropriate design. This led to some out-of-specification issues in drug products manufactured using those equipments. Water system used in the building also had deficiencies.

• Input and output from computer and records are not checked for accuracy. Inventory reconciliation issues were observed.

• Lack of appropriate controls over computers and related systems (only one general ID and password used for testing process) to assure that changes in master production and control records are made by authorised personnel only. This is a repeat observation.

Laboratory Control System

• Routine calibration, inspection and checking of equipment is not performed according to the written program designed. Stability chambers are not mapped periodically for temperatures and weights and scales used routinely for weighing materials are not verified.

• This is a repeat observation that states laboratory controls do not include appropriate standards and tests to assure that the components (water and APIs and other raw materials used in manufacturing) conform to appropriate standards of identity, strength, quality and purity.

• Laboratory records (specifically injection and data reconciliations) do not include complete data required to assure compliance with established specifications and standards.

• Stability samples are not stored appropriately and there is no assurance that the methods used for testing stability are able to detect al potential impurities.

Lupin has yet to respond to BQ Prime’s emailed queries.

But the drugmaker in the filing had said it was confident of addressing these observations and would “work closely with the agency to address their concerns”. “We uphold quality and compliance with utmost importance and are committed to be compliant with good manufacturing practice standards across all our facilities.”

The company, the filing said, doesn’t believe that this will have an impact on disruption of supplies or the existing revenue from operations of this facility. “The facility contributes less than 5% of the company’s global revenue.”

But Nirmal Bang’s pharma analyst Vishal Manchanda said the observations might impact future product approvals from the facility.

Recently, Lupin’s Tarapur, Maharashtra facility, manufacturing active pharmaceutical ingredients, was also issued a Form 483 with four observations. The inspection was completed on April 4.

Shares of Lupin have fallen 3.04% since March 31, when the inspected ended, compared with a 4.69% decline in Nifty 50.