Dr Reddy's Laboratories Limited
Form 483 issued January 15, 2019 · Ranashthalam Mandal, Srikakulam, India
- Inspection
- Jan 7 – Jan 15, 2019
- Investigators
- Justin A. Boyd· Rumany C. Penn
- Observations
- 3
- Pages
- 4
- FEI number
- 3009193040
In short: On January 15, 2019, FDA issued a Form 483 with 3 observations to Dr Reddy's Laboratories Limited in Ranashthalam Mandal, Srikakulam, India (FEI 3009193040) after an inspection that ran Jan 7 – Jan 15, 2019. The investigators were Justin A. Boyd and Rumany C. Penn. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test . procedures designed…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmDr Reddy's Laboratories Limited history
All 4 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 Dr Reddy's Laboratories Limited?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Dr Reddy's Laboratories Limited?
Justin A. Boyd and Rumany C. Penn are named on this Form 483, for the inspection of Jan 7 – Jan 15, 2019. Each investigator has a profile showing what they cite most.
When was Dr Reddy's Laboratories Limited inspected by FDA?
The inspection ran Jan 7 – Jan 15, 2019, and the Form 483 is dated January 15, 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.