# USFDA inspections of Dr. Reddy’s Laboratories plants

> Live situation record from CLSTR: https://clstr.news/situations/usfda-inspections-of-dr-reddys-laboratories-plants
> Updated: 2026-10-15T05:37:13.000Z. Sources: 2. Developments: 2.

Dr. Reddy’s Laboratories has faced multiple USFDA regulatory observations following pre-approval inspections at its manufacturing facilities in Andhra Pradesh.

On October 8, 2026, the company reported receiving a USFDA Form 483 containing two observations after an inspection of its FTO-11 facility in Pydibhimavaram conducted between October 5 and October 7. The company stated it intends to address these observations within the regulator’s stipulated timeframe.

Following this, on October 15, 2026, it was reported that the USFDA issued a Form 483 with three observations after a pre-approval inspection at the FTO-9 facility in Visakhapatnam, which took place from October 8 to October 9. Dr. Reddy’s indicated it would provide a corrective response within the required timeline. These incidents follow previous observations at the company’s Pydibhimavaram and Srikakulam plants.

## Timeline

### 2026-10-15: Dr. Reddy's receives three USFDA observations at Visakhapatnam plant

The USFDA issued three observations via a Form 483 following a pre-approval inspection at Dr. Reddy’s Laboratories’ FTO-9 facility in Visakhapatnam, India.

2 sources. https://clstr.news/cluster/dr-reddys-receives-three-usfda-observations-at-visakhapatnam-plant

### 2026-10-08: Dr. Reddy's Laboratories receives USFDA observations at Andhra Pradesh plant

Dr. Reddy's Laboratories received two USFDA Form 483 observations following a pre-approval inspection at its FTO-11 manufacturing facility in Andhra Pradesh, India.

2 sources. https://clstr.news/cluster/dr-reddys-laboratories-receives-usfda-observations-at-andhra-pradesh-plant

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Cite as: USFDA inspections of Dr. Reddy’s Laboratories plants. CLSTR, https://clstr.news/situations/usfda-inspections-of-dr-reddys-laboratories-plants