US FDA issued five observations to Zydus Lifesciences after inspecting its Moraiya plant in Gujarat from Oct 5-13. Zydus will address them.

The company said it will work closely with the regulator to resolve the issues as quickly as possible.

Inspectors issue a Form 483 at the end of a visit when they spot practices that may break the rules. It is not a final verdict.

The FDA’s own form says the points come from the inspection and are not a ruling on whether the plant complies. The form was issued on 13 October, the last day of the visit.

It describes Moraiya, in Sanand near Ahmedabad, as a maker of non-sterile drugs, meaning medicines that do not have to be made in a germ-free setting.

Zydus is among India’s biggest drugmakers. Sources, which reported on the form, listed what the inspectors found.

In the quality lab, test plates with clear signs of growth were logged as ‘no growth’ on two records, one for a six-month stability sample and one for an incoming raw material.

A second person then signed off on them. Staff also did not dig deep enough into unexplained results, including a metal shavings complaint that ended in a recall.

Some US products with repeated off-trend results went out without a root cause being found. The other three were about procedures.

Zydus had no written process under US supply chain law for handling suspect products, a lab identity test went unverified for three years, and the plant kept testing incoming materials less often even after some failed.

The form says reduced testing continued despite particle size failures in 2023, 2024 and 2026. A separate approval followed soon after.

On 21 October, eight days after the inspection ended, the US FDA gave final approval to a Zydus hormone patch made at the same Moraiya plant.

The product, an estradiol and levonorgestrel transdermal system, comes with 180 days of marketing exclusivity under the FDA’s competitive generic therapy rules.

The regulator will weigh the company’s response before it classifies the inspection. For now, the observations remain findings, not penalties.

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