Dr. Reddy's Laboratories Limited
Form 483 issued October 25, 2019 · Srikakulam, India
- Inspection
- Oct 21 – Oct 25, 2019
- Investigator
- Dipesh K. Shah
- Observations
- 4
- Pages
- 3
- FEI number
- 3005336882
In short: On October 25, 2019, FDA issued a Form 483 with 4 observations to Dr. Reddy's Laboratories Limited in Srikakulam, Andhra Pradesh (FEI 3005336882) after an inspection that ran Oct 21 – Oct 25, 2019. The investigator was Dipesh K. Shah. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 4 of 4 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
Observation 1: scanned text, readable in the full document.
- 02
Your firm’s cleaning processes for non-dedicated equipment have not been adequately evaluated. V, 18/001 which is…
- 03
Production equipment is not stored appropriately to prevent contamination or carry-over of a material that would…
- 04
Your Quality Unit lacked oversight…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
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
The site's inspection history, in date order.
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 Dr. Reddy's Laboratories Limited?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Limited?
Dipesh K. Shah is named on this Form 483, for the inspection of Oct 21 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Limited inspected by FDA?
The inspection ran Oct 21 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
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.