Megafine Pharma (P) Limited
Form 483 issued May 12, 2023 · Vapi, India
- Inspection
- May 8 – May 12, 2023
- Investigators
- Lisa L. Flores· Rafeeq Habeeb
- Observations
- 2
- Pages
- 3
- FEI number
- 3006688078
In short: On May 12, 2023, FDA issued a Form 483 with 2 observations to Megafine Pharma (P) Limited in Vapi, Gujarat (FEI 3006688078) after an inspection that ran May 8 – May 12, 2023. The investigators were Lisa L. Flores and Rafeeq Habeeb. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Written records of investigations into unexplained discrepancies and failures of batches and/or components to meet specifications…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmMegafine Pharma (P) Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Megafine Pharma (P) Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Megafine Pharma (P) Limited?
Lisa L. Flores and Rafeeq Habeeb are named on this Form 483, for the inspection of May 8 – May 12, 2023. Each investigator has a profile showing what they cite most.
When was Megafine Pharma (P) Limited inspected by FDA?
The inspection ran May 8 – May 12, 2023, and the Form 483 is dated May 12, 2023.
How do I get the full Form 483 for Megafine Pharma (P) Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.