Archive · 12 Sep 2026
Dr Reddy’s Mexico API Facility Gets Two USFDA Observations
Dr Reddy’s makes pharmaceutical ingredients at a facility in Mexico.
The United States Food and Drug Administration reviewed documents and records from that facility.
This review happened from July 17 to September 8, 2026.
The facility is called Industrias Químicas Falcon de México, SA de CV.
After the review, the regulator listed two observations, which are issues or points requiring attention.
The observations were included in a form called Form FDA 2953.
Dr Reddy’s did not publicly explain what the observations were.
The company said it would reply to the regulator within the required time.
The United States Food and Drug Administration completed a records assessment of Dr Reddy’s API facility in Mexico.
The assessment involved Industrias Químicas Falcon de México, SA de CV, a Dr Reddy’s Laboratories facility.
The review took place from July 17 to September 8, 2026.
The USFDA issued two observations in Form FDA 2953 after completing the assessment.
Dr Reddy’s did not disclose the observations’ details and said it would respond within the stipulated timeline.
- Who
- The United States Food and Drug Administration assessed a Dr Reddy’s Laboratories facility.
- What
- The USFDA completed a records assessment and issued two observations in Form FDA 2953.
- When
- The assessment took place from July 17 to September 8, 2026, and the company disclosed it on September 12, 2026.
- Where
- At Industrias Químicas Falcon de México, SA de CV, an API manufacturing facility in Mexico.
- Why
- The USFDA reviewed the facility’s documents and records to evaluate compliance with regulatory requirements.
- Company
- Dr Reddy’s Laboratories
- Regulator
- United States Food and Drug Administration
- Facility
- Industrias Químicas Falcon de México, SA de CV
- Location
- Mexico
- Assessment type
- USFDA records assessment
- Assessment period
- July 17 to September 8, 2026
- Observations
- Two observations issued in Form FDA 2953
- Company response
- Dr Reddy’s said it would respond within the stipulated timeline
