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Dr Reddy’s Mexico API Facility Receives Two USFDA Observations
Dr Reddy’s makes pharmaceutical ingredients at a facility in Mexico.
The United States Food and Drug Administration reviewed the facility’s records.
The review happened from July 17 to September 8, 2026.
After checking the records, the regulator identified two issues called observations.
These observations were listed in an official form.
Dr Reddy’s did not publicly explain what the two observations were.
The company said it will answer the regulator within the required time.
The review was a records assessment rather than a publicly described inspection of manufacturing operations.
The USFDA completed a records assessment of Dr Reddy’s API manufacturing facility in Mexico.
The assessment took place from July 17 to September 8, 2026.
The facility assessed was Industrias Químicas Falcon de México, SA de CV.
The USFDA issued two observations in Form FDA 2953 after the assessment.
Dr Reddy’s said it will respond within the stipulated timeline, without detailing the observations.
- 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.
- Where
- At Industrias Químicas Falcon de México, SA de CV, an active pharmaceutical ingredient manufacturing facility in Mexico.
- When
- The assessment took place from July 17 to September 8, 2026; the company disclosed it on September 12, 2026.
- Why
- The USFDA conducted a regulatory review of the facility’s documentation and records to evaluate compliance.
Key facts
- 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 will respond within the stipulated timeline
Quotes
Dr Reddy’s Laboratories
Pharmaceutical company reporting the outcome of the USFDA assessment
“At the conclusion of the assessment, the USFDA issued a Form FDA 2953 containing two observations, to which we will respond within the stipulated timeline.”
thehindubusinessline.com
Sources
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