Megafine Pharma (P) Limited
Form 483 issued January 24, 2023 · Nashik, India
- Inspection
- Jan 17 – Jan 24, 2023
- Observations
- 7
- Pages
- 11
- FEI number
- 3005694111
In short: On January 24, 2023, FDA issued a Form 483 with 7 observations to Megafine Pharma (P) Limited in Nashik, Maharashtra (FEI 3005694111) after an inspection that ran Jan 17 – Jan 24, 2023. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(REPEAT) Failure of quality unit to exercise its responsibility to ensure the Active Pharmaceutical Ingredients (APIs)…
- 02
REPEAT OBSERVATION Written records of investigations are deficient in determining the root cause of failure to…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination…
- 04
Appropriate controls governing computer acquired data and/or related systems have not been established to assure that…
This inspection in context
Questions about this 483
What did FDA find at Megafine Pharma (P) Limited?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Megafine Pharma (P) Limited inspected by FDA?
The inspection ran Jan 17 – Jan 24, 2023, and the Form 483 is dated January 24, 2023.
How do I get the full Form 483 for Megafine Pharma (P) Limited?
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