MADHU INSTRUMENTS PRIVATE LIMITED
Form 483 issued October 21, 2022 · New Deli, India
- Inspection
- Oct 11 – Oct 21, 2022
- Observations
- 11
- Pages
- 20
- FEI number
- 3007317099
In short: On October 21, 2022, FDA issued a Form 483 with 11 observations to MADHU INSTRUMENTS PRIVATE LIMITED in New Deli, India (FEI 3007317099) after an inspection that ran Oct 11 – Oct 21, 2022. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
REPEAT OBSERVATION Your firm failed to establish an adequate quality control unit with the responsibility and…
- 02
Investigations of an unexplained discrepancy into a failure of a batch or any of its components…
- 03
REPEAT OBSERVATION Employees engaged in the manufacture, processing, packing, holding of a drug product lack the…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product to not the…
This inspection in context
Questions about this 483
What did FDA find at MADHU INSTRUMENTS PRIVATE LIMITED?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was MADHU INSTRUMENTS PRIVATE LIMITED inspected by FDA?
The inspection ran Oct 11 – Oct 21, 2022, and the Form 483 is dated October 21, 2022.
How do I get the full Form 483 for MADHU INSTRUMENTS 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.