Mankind Pharma Limited
Form 483 issued April 26, 2025 · Kotputli-Behror, India
- Inspection
- Apr 22 – Apr 26, 2025
- Observations
- 10
- Pages
- 15
- FEI number
- 3014150265
In short: On April 26, 2025, FDA issued a Form 483 with 10 observations to Mankind Pharma Limited in Kotputli-Behror, Rajasthan (FEI 3014150265) after an inspection that ran Apr 22 – Apr 26, 2025. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.142 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Production records do not contain complete information relating to the production and…
- 04
Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
This inspection in context
Questions about this 483
What did FDA find at Mankind Pharma Limited?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
When was Mankind Pharma Limited inspected by FDA?
The inspection ran Apr 22 – Apr 26, 2025, and the Form 483 is dated April 26, 2025.
How do I get the full Form 483 for Mankind Pharma Limited?
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