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Alkem Labs Gets 7 USFDA Observations at Daman Plant After Inspection

Alkem Laboratories received seven Form 483 observations from the USFDA after a 12-day inspection at its Daman plant. The company will respond to all observations within the stipulated timeline. This follows a positive regulatory milestone in March when the facility received EU GMP compliance. Separately, Lupin also received a Form 483 with three observations from the USFDA last month.

Key Points: Alkem Labs Gets 7 USFDA Observations at Daman Plant

  • USFDA issued 7 Form 483 observations at Alkem's Daman plant
  • Inspection lasted 12 days from April 20 to May 1
  • Alkem to respond within stipulated timeline
  • Facility had received EU GMP compliance in March
  • Lupin also got 3 observations from USFDA last month
2 min read

Alkem Labs gets 7 USFDA observations at Daman Plant after inspection

Alkem Laboratories receives 7 USFDA Form 483 observations at its Daman facility after a 12-day inspection, impacting regulatory compliance.

"The inspection was completed with the issuance of a Form 483 carrying three observations - Lupin"

New Delhi, May 3

Pharmaceutical major Alkem Laboratories has come under regulatory scrutiny after the United States Food and Drug Administration issued inspectional observations at its manufacturing facility in Amaliya, Daman, following a recent audit.

The inspection, conducted over 12 days from April 20 to May 1, concluded with the issuance of a Form 483, in which the US regulator flagged seven observations.

A Form 483, formally known as a "Notice of Inspectional Observations," is issued when investigators identify conditions that may potentially violate provisions of the Food, Drug and Cosmetic Act, particularly those related to manufacturing practices, quality systems, or product safety.

While the company acknowledged receiving the observations, it did not disclose specific details about the issues raised by the regulator.

Alkem Laboratories said it would respond to all seven observations within the stipulated timeline.

The development was formally communicated to the BSE Limited and the National Stock Exchange of India on May 2, 2026, in line with regulatory disclosure requirements.

The latest scrutiny comes weeks after a positive regulatory milestone for the company. In March, Alkem Laboratories announced that its Daman facility had received a Good Manufacturing Practice (GMP) compliance certificate from the Malta Medicines Authority.

The certification followed an inspection conducted on December 9, 2025, and confirmed that the facility met European Union GMP standards. The certificate is valid for a period of three years.

Meanwhile, last month, US health regulator issued a 'Form 483' with three observations to drug maker Lupin.

In a regulatory filing, the pharmaceutical company said that the inspection by the US Food and Drug Administration (USFDA) was conducted this week between April 13 and April 17.

"The inspection was completed with the issuance of a Form 483 carrying three observations," the drug maker said.

- IANS

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Reader Comments

P
Priya S
This is concerning. Alkem is a major player and these observations could impact exports. But I'm glad the company is being transparent with the stock exchanges. Let's hope they fix the issues quickly and maintain their reputation. India's pharma sector can't afford another blow 🇮🇳
V
Vikram M
Genuine question - why do USFDA inspections always seem to find issues with Indian pharma companies? Is it a standards gap or bias? Alkem got EU GMP certification just months ago, so something doesn't add up. Would appreciate a deeper investigation into their processes.
J
James A
As a US consumer, I rely on Indian generics for affordable medicine. Hope Alkem addresses these observations seriously - 7 issues is a lot for a 12-day inspection. The industry needs to maintain high standards or we'll all lose access to cost-effective drugs.
R
Rohit P
Ye sab dekh ke lagta hai ki Indian pharma companies ko apna quality control seriously lena chahiye. EU certification milna achcha hai, lekin USFDA ko satisfy karna bhi important hai. Alkem ne bola hai ki wo timeline mein respond karega - let's see what happens. Fingers crossed 🤞
S
Sarah B
Interesting that Lupin also got a Form 483 with 3 observations last month. Makes me wonder if there's a pattern in Indian pharma's approach to quality systems. Not trying to be negative, but these repeated issues deserve closer scrutiny from regulators and companies alike.

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