USFDA completes Pre-Approval Inspection at FTO-11 plant; Form 483 with two observations issued

USFDA completed a Pre-Approval Inspection (PAI) at the company's FTO-11 facility in Pydibhimavaram, Andhra Pradesh.

Thu 8 Oct 2026

Facility

FTO-11 facility in Pydibhimavaram, Andhra Pradesh

Inspection dates

October 5, 2026 to October 7, 2026

Inspection outcome

Form 483 with two observations

What the company told the exchanges

The United States Food and Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) at the company's FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh. The inspection was conducted from October 5, 2026 to October 7, 2026. The company has been issued a Form 483 with two observations. The company states that it will address the observations within the stipulated timeline.

What a Form 483 is

• A Form 483 is the form USFDA investigators use to record observations made during an inspection of a facility.
• It lists conditions the investigator believes may indicate deviations from applicable requirements.
• It is issued at the close of an inspection, and the company is expected to respond to the observations.
• A Pre-Approval Inspection is an inspection tied to a product approval application linked to the site.

What to note in the numbers

• The facility involved is the FTO-11 plant at Pydibhimavaram, Andhra Pradesh.
• The number of observations recorded is two.

What the company said about next steps

The company said the observations will be addressed within the stipulated timeline.

How a reader can place this

• This is a disclosure of the outcome of a regulatory inspection at one manufacturing site.
• The company's stated position is that it will respond to the observations within the timeline set for it.

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