Lupin receives Form 483 after product contaminated with human hair

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Gcsherman1)
(Image: Getty/Gcsherman1)
US FDA issues Lupin with a Form 483 based on three observations during a recent inspection at its Aurangabad site.

The US Food and Drug Administration (FDA) inspection took place from May 5 to May 15, 2019, at Lupin’s Maharashtra state, India, facility.

In total, the Form 483​ noted three observations regarding production issues at the finished drug site, with the most notable issue being a failure to file written records of inspections regarding faults discovered internally.

The heavily redacted first observation stated that from the period July 2017 until February 2019, the testing of tablets produced at the site led the company to discover products were out of specification.

However, the FDA observed that no corrective actions were taken at the time, as well as employees concluding “manual errors”​ were part of the cause not filing documentation regarding what type of manual error.

In one instance, a complaint regarding a human hair being embedded within a tablet did not result in an expanded investigation “to determine microbial contamination or impact.”

The report goes on to note that “Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards sampling plans and test procedures designed to assure that components, in-process materials and drug products confirm to appropriate standards of identity, strength, quality and purity.”

Lupin’s Aurangabad site is home to a formulations plant and an R&D centre, as well as producing anti-tuberculosis medicine.

In a statement, the company noted that it is “confident of addressing [the observations] satisfactorily.”

The company has faced previous regulatory action from FDA regarding product recalls and inspections, towards the end of last year and the beginning of 2019​.

Launches product on US market

On the same day that the FDA made its Form 483 public, Lupin confirmed that it had launched its budesonide inhalation suspension, 0.5 mg/2 mL single-dose ampules onto the US market.

The medication is a generic version of AstraZeneca’s Pulmicort product, which the company lost patent protection​ on in 2015.

The product is a maintenance treatment for asthma in children from 12 months to eight years of age.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Manufacturing Drugs with Highly Potent APIs

Manufacturing Drugs with Highly Potent APIs

Content provided by Altasciences | 28-Sep-2023 | White Paper

In this issue of The Altascientist, we examine the critical considerations for the safe and compliant manufacture of drugs with highly potent APIs (HPAPIs),...

Follow us

Products

View more

Webinars