Dr. Reddy's Laboratories Ltd.
Form 483 issued April 4, 2017 · Srikakulam District, India
- Inspection
- Mar 27 – Apr 4, 2017
- Investigators
- Gayle S. Lawson· Kenneth H. Williams
- Observations
- 2
- Pages
- 1
- FEI number
- 3002949085
In short: On April 4, 2017, FDA issued a Form 483 with 2 observations to Dr. Reddy's Laboratories Ltd. in Srikakulam District, India (FEI 3002949085) after an inspection that ran Mar 27 – Apr 4, 2017. The investigators were Gayle S. Lawson and Kenneth H. Williams. Most observations concern laboratory controls.
At a glance
2 of 2 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complete records are not always maintained for periodic calibration of laboratory instruments, apparatus, gauges, and recording…
- 02
Laboratory records do not include a complete record of all data secured in the course of…
This inspection in context
Gayle S. Lawson
10 documents · 2015–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmDr. Reddy's Laboratories Ltd. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Ltd.?
Gayle S. Lawson and Kenneth H. Williams are named on this Form 483, for the inspection of Mar 27 – Apr 4, 2017. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. inspected by FDA?
The inspection ran Mar 27 – Apr 4, 2017, and the Form 483 is dated April 4, 2017.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd.?
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.