Aurobindo Pharma Unit-VII Receives 9 USFDA Form 483 Observations

Aurobindo Pharma is expected to draw investor attention after the US Food and Drug Administration (USFDA) issued a Form 483 with a total of 9 observations. The development follows an inspection at the company’s Unit‑VII, an oral solid dosage manufacturing facility located in the Special Economic Zone (Pharma), TSIIC, Green Industrial Park.

The company disclosed the update through an exchange filing, highlighting the regulatory findings. This comes shortly after a previous USFDA inspection at its Unit‑III manufacturing facility reported on February 9.

Details Of the USFDA Inspection at Unit‑VII

The USFDA conducted an inspection at Aurobindo Pharma’s Unit‑VII facility, covering manufacturing practices associated with oral solid dosage forms. At the conclusion of the audit, the regulator issued a Form 483 containing 9 observations.

These observations typically document areas where the facility may be falling short of regulatory expectations. The company has acknowledged the findings and is expected to provide corrective actions as part of the compliance process.

Nature Of Form 483 Observations

A Form 483 is issued when USFDA inspectors identify potential regulatory deviations during an inspection. The document may include concerns related to equipment, facility conditions, production processes, quality controls, employee practices, or documentation standards.

In the case of Aurobindo Pharma, the observations indicate areas where the company may need to strengthen its operational or quality systems. Companies generally respond to such observations with a detailed plan addressing each finding.

Previous Inspection Conducted at Unit‑III

Aurobindo Pharma recently reported that the USFDA had inspected its Unit‑III manufacturing facility prior to this development. The inspection at Unit‑III took place earlier and was disclosed by the company on February 9.

The occurrences of two inspections in close succession highlight ongoing regulatory scrutiny across multiple units of the organisation. The outcomes of both inspections will be closely monitored by market participants and stakeholders.

Aurobindo Pharma Share Price Performance

On February 11, 2026, Aurobindo Pharma share price opened at ₹1,136.00, compared to the previous close of ₹1,124.10. During the session, as of 2:16 PM IST, the stock had touched a high of ₹1,161.00 and a low of ₹1,124.20, and was trading at ₹1,149.80, up by 2.16%.

The stock recorded a traded volume of 32.34 lakh shares and a traded value of ₹370.42 crore on the NSE. The market capitalisation stood at ₹66,780.57 crore.

Read More: Sun Pharma Bets on Innovation as US Generics Pressure Eases, Speciality Drugs Drive Growth.

Conclusion

The USFDA’s issuance of a Form 483 with 9 observations to Aurobindo Pharma’s Unit‑VII places the company under regulatory watch. The development follows a similar inspection at its Unit‑III facility, adding to recent compliance‑related updates.

Aurobindo Pharma will now work on addressing the regulatory concerns raised at the Unit‑VII site. The market is expected to track the company’s responses and subsequent regulatory actions closely.

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