DR.REDDY'S Laboratories LIMITED
Form 483 issued October 29, 2021 · Duvvada, India
- Inspection
- Oct 18 – Oct 29, 2021
- Investigators
- Nancy M. Espinal· Rita K. Kabaso
- Observations
- 8
- Pages
- 18
- FEI number
- 3006549835
In short: On October 29, 2021, FDA issued a Form 483 with 8 observations to DR.REDDY'S Laboratories LIMITED in Duvvada, Andhra Pradesh (FEI 3006549835) after an inspection that ran Oct 18 – Oct 29, 2021. The investigators were Nancy M. Espinal and Rita K. Kabaso. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedmes applicable to the quality control unit are not in writing and fully…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmDR.REDDY'S Laboratories LIMITED history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DR.REDDY'S Laboratories LIMITED?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected DR.REDDY'S Laboratories LIMITED?
Nancy M. Espinal and Rita K. Kabaso are named on this Form 483, for the inspection of Oct 18 – Oct 29, 2021. Each investigator has a profile showing what they cite most.
When was DR.REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Oct 18 – Oct 29, 2021, and the Form 483 is dated October 29, 2021.
How do I get the full Form 483 for DR.REDDY'S Laboratories 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.