Warning letter and Form 483 received by Indoco made public

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Dzyuba)
(Image: Getty/Dzyuba)

Related tags Indoco Remedies India Fda Form 483 Warning letter

Indoco confirms receipt of a warning letter from the US FDA and the agency posts details of a Form 483 for two different facilities in the space of one week.

Indoco Remedies issued a statement that it had received a warning letter from the US Food and Drug Administration (FDA) regarding its oral dosage plant, based in Goa, India.

The warning letter followed on from a Form 483 that had been issued to the company in March 2019, which detailed six observations that needed to be rectified.

In turn, the FDA also revealed details on a further Form 483​ regarding issues at Indoco’s Goa Plant 1 site, where the company produces tablets. The facility received four observations, regarding inspections into out-of-specifications batches and incomplete data laboratory records.

In response to the issues, Aditi Panandikar, MD for Indoco, said, “We have already done considerable remediation work and shall continue to implement necessary additional corrective actions.”

Continuing, “We are committed to being cGMP (current good manufacturing practice) compliant and supplying quality products to our customers and patients across the globe.”

Further than this, the company stated that it was already working with a cGMP consultant in order to address the issues noted in the warning letter.

The company currently has one approved abbreviated new drug application (ANDA) from the site, with four pending ANDAs. It was stated that the approvals may be withheld until the issues noted by the FDA are rectified.

As a result of the regulatory action, shares in the company had fallen 2.45%, at the time of writing.

This latest batch of regulatory issues follows on from previous a warning that the active pharmaceutical ingredients (APIs) and finished formulation maker had experienced.

In April 2017​, the company had received a warning letter regarding a plant, also based in Goa, after concerns aboutthe latanoprost ophthalmic solution produced at the facility and the possibility that there was leakage of product.

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