Maiva Pharma Private Limited
Form 483 issued October 29, 2022 · Hosur, India
- Inspection
- Oct 20 – Oct 29, 2022
- Investigators
- Dipesh K. Shah· Thomas J. Arista
- Observations
- 6
- Pages
- 14
- FEI number
- 3014362214
In short: On October 29, 2022, FDA issued a Form 483 with 6 observations to Maiva Pharma Private Limited in Hosur, Tamil Nadu (FEI 3014362214) after an inspection that ran Oct 20 – Oct 29, 2022. The investigators were Dipesh K. Shah and Thomas J. Arista. Most observations concern facilities & equipment and production.
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of adequate…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maiva Pharma Private Limited?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Maiva Pharma Private Limited?
Dipesh K. Shah and Thomas J. Arista are named on this Form 483, for the inspection of Oct 20 – Oct 29, 2022. Each investigator has a profile showing what they cite most.
When was Maiva Pharma Private Limited inspected by FDA?
The inspection ran Oct 20 – Oct 29, 2022, and the Form 483 is dated October 29, 2022.
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.