DR.REDDY'S Laboratories LIMITED
Form 483 issued October 30, 2018 · Visakhapatnam, India
- Inspection
- Oct 22 – Oct 30, 2018
- Investigators
- Jose E. Melendez· Junho Pak
- Observations
- 1
- Pages
- 10
- FEI number
- 3006549835
In short: On October 30, 2018, FDA issued a Form 483 with 1 observation to DR.REDDY'S Laboratories LIMITED in Visakhapatnam, India (FEI 3006549835) after an inspection that ran Oct 22 – Oct 30, 2018. The investigators were Jose E. Melendez and Junho Pak. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.100
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected DR.REDDY'S Laboratories LIMITED?
Jose E. Melendez and Junho Pak are named on this Form 483, for the inspection of Oct 22 – Oct 30, 2018. Each investigator has a profile showing what they cite most.
When was DR.REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Oct 22 – Oct 30, 2018, and the Form 483 is dated October 30, 2018.
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.