Malladi Drugs & Pharmaceuticals Limited
Form 483 issued September 8, 2017 · Ranipet, India
- Investigator
- Oes Tq
- Observations
- 8
- Pages
- 6
- FEI number
- 3005115135
In short: On September 8, 2017, FDA issued a Form 483 with 8 observations to Malladi Drugs & Pharmaceuticals Limited in Ranipet, Tamil Nadu (FEI 3005115135). The investigator was Oes Tq. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and production account for 6 of 8 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality Unit failed…
- 02
Process validation for was…
- 03
Batch production records do not include complete information relating to the…
- 04
The facility is not designed…
This inspection in context
Oes Tq
1 document · 2017
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in India.
The firmMalladi Drugs & Pharmaceuticals Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Malladi Drugs & Pharmaceuticals Limited?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 Limited?
Oes Tq is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Malladi Drugs & Pharmaceuticals Limited inspected by FDA?
This Form 483 is dated September 8, 2017.
How do I get the full Form 483 for Malladi Drugs & Pharmaceuticals 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.