Maiva Pharma Private Limited
Form 483 issued February 20, 2026 · Hosur, India
- Inspection
- Feb 10 – Feb 20, 2026
- Investigators
- Alan A. Rivera· Jose E. Melendez
- Observations
- 9
- Pages
- 26
- FEI number
- 3014362214
In short: On February 20, 2026, FDA issued a Form 483 with 9 observations to Maiva Pharma Private Limited in Hosur, Tamil Nadu (FEI 3014362214) after an inspection that ran Feb 10 – Feb 20, 2026. The investigators were Alan A. Rivera and Jose E. Melendez. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Production records do not contain complete information relating to the production and…
- 02
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 03
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmMaiva Pharma Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maiva Pharma Private Limited?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Maiva Pharma Private Limited?
Alan A. Rivera and Jose E. Melendez are named on this Form 483, for the inspection of Feb 10 – Feb 20, 2026. Each investigator has a profile showing what they cite most.
When was Maiva Pharma Private Limited inspected by FDA?
The inspection ran Feb 10 – Feb 20, 2026, and the Form 483 is dated February 20, 2026.
How do I get the full Form 483 for Maiva Pharma Private 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.