FDA-Inspected Site

Maiva Pharma Private Limited

4 FDA inspections are on record for Maiva Pharma Private Limited in Hosur, India.

483· Form 483 issued

Hosur, India · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-20.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Feb 2026 – 20 Feb 2026Human Drugs483On file
14 Jul 2025 – 22 Jul 2025Human Drugs483View 483 →
20 Oct 2022 – 29 Oct 2022Human Drugs483View 483 →
24 Jul 2019 – 2 Aug 2019Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

22 Jul 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Saleem A Akhtar

22 Jul 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Saleem A Akhtar

22 Jul 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Saleem A Akhtar

22 Jul 2025
21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Saleem A Akhtar

22 Jul 2025
21 CFR 211.42(c)(10)

Aseptic Processing Area

Cited by Saleem A Akhtar

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.46(c)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Maiva Pharma Private Limited's 4 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat