Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal
Form 483 issued April 28, 2017 · Bachupally, India
- Inspection
- Apr 19 – Apr 28, 2017
- Investigators
- Angela E. Glenn· Cheryl Clausen
- Observations
- 2
- Pages
- 8
- FEI number
- 3002949099
In short: On April 28, 2017, FDA issued a Form 483 with 2 observations to Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal in Bachupally, India (FEI 3002949099) after an inspection that ran Apr 19 – Apr 28, 2017. The investigators were Angela E. Glenn and Cheryl Clausen. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmDr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
Angela E. Glenn and Cheryl Clausen are named on this Form 483, for the inspection of Apr 19 – Apr 28, 2017. Each investigator has a profile showing what they cite most.
When was Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal inspected by FDA?
The inspection ran Apr 19 – Apr 28, 2017, and the Form 483 is dated April 28, 2017.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
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