Archive · 19 May 2025
Dr. Reddy's Receives Observations from USFDA for New York Plant
Imagine a health inspector visited a factory that makes medicine parts.
They found some things that weren't quite right.
The factory, Dr. Reddy's, got a note from the inspector, called a Form 483, with two points to fix.
The inspection happened in New York from May 12-16, 2025.
The company is now working to fix the problems within a specific time frame, as requested by the inspector.
These issues may mean the factory didn't completely follow the rules for making medicines.
Dr. Reddy's received a Form 483 with two observations from the USFDA.
The inspection was conducted at the company's Middleburgh, New York facility.
The inspection focused on the API (active pharmaceutical ingredients) facility.
The inspection occurred from May 12-16, 2025.
Dr. Reddy's will address the observations within a set timeframe.
- Who
- Dr. Reddy's Laboratories
- What
- The USFDA inspected Dr. Reddy's API facility and issued a Form 483 with two observations.
- When
- May 12-16, 2025
- Where
- Middleburgh, New York
- Why
- The USFDA issued a Form 483 after observing potential violations.
- Company
- Dr. Reddy's Laboratories
- Facility Location
- Middleburgh, New York
- Type of Facility
- API (active pharmaceutical ingredients)
- Inspection Dates
- May 12-16, 2025
- Regulatory Body
- USFDA
- Observations
- Two
- Form Issued
- Form 483