Maiva Pharma Private Limited
Form 483 issued August 2, 2019 · Hosur, India
- Inspection
- Jul 24 – Aug 2, 2019
- Investigator
- Samina S. Khan
- Observations
- 2
- Pages
- 2
- FEI number
- 3014362214
In short: On August 2, 2019, FDA issued a Form 483 with 2 observations to Maiva Pharma Private Limited in Hosur, Tamil Nadu (FEI 3014362214) after an inspection that ran Jul 24 – Aug 2, 2019. The investigator was Samina S. Khan. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Samina S. Khan
5 documents · 2015–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maiva Pharma Private Limited?
FDA listed 2 observations on this Form 483, mostly about quality system 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.
Who inspected Maiva Pharma Private Limited?
Samina S. Khan is named on this Form 483, for the inspection of Jul 24 – Aug 2, 2019. Each investigator has a profile showing what they cite most.
When was Maiva Pharma Private Limited inspected by FDA?
The inspection ran Jul 24 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
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.