Mankind Pharma Limited
Form 483 issued February 25, 2022 · Paonta Sahib, India
- Inspection
- Feb 14 – Feb 25, 2022
- Observations
- 6
- Pages
- 18
- FEI number
- 3009083745
In short: On February 25, 2022, FDA issued a Form 483 with 6 observations to Mankind Pharma Limited in Paonta Sahib, Himachal Pradesh (FEI 3009083745) after an inspection that ran Feb 14 – Feb 25, 2022. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Questions about this 483
What did FDA find at Mankind Pharma Limited?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
When was Mankind Pharma Limited inspected by FDA?
The inspection ran Feb 14 – Feb 25, 2022, and the Form 483 is dated February 25, 2022.
How do I get the full Form 483 for Mankind Pharma Limited?
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