Malladi Drugs & Pharmaceuticals Pvt Ltd
Form 483 issued October 9, 2018 · GajuJamandyant, India
- Inspection
- Oct 1 – Oct 9, 2018
- Investigator
- Kellia N. Hicks
- Observations
- 2
- Pages
- 8
- FEI number
- 3010212308
In short: On October 9, 2018, FDA issued a Form 483 with 2 observations to Malladi Drugs & Pharmaceuticals Pvt Ltd in GajuJamandyant, India (FEI 3010212308) after an inspection that ran Oct 1 – Oct 9, 2018. The investigator was Kellia N. Hicks. 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×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Batch production and laboratory control records of critical process steps are not reviewed and approved'by the…
- 02
Contro! procedures are not followed which monitor the output and validate the performance of those manufacturing…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMalladi Drugs & Pharmaceuticals Pvt Ltd history
All 2 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 Malladi Drugs & Pharmaceuticals Pvt Ltd?
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 Malladi Drugs & Pharmaceuticals Pvt Ltd?
Kellia N. Hicks is named on this Form 483, for the inspection of Oct 1 – Oct 9, 2018. Each investigator has a profile showing what they cite most.
When was Malladi Drugs & Pharmaceuticals Pvt Ltd inspected by FDA?
The inspection ran Oct 1 – Oct 9, 2018, and the Form 483 is dated October 9, 2018.
How do I get the full Form 483 for Malladi Drugs & Pharmaceuticals Pvt Ltd?
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.