Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal
Form 483 issued February 8, 2019 · Bachupally, India
- Inspection
- Jan 30 – Feb 8, 2019
- Investigators
- Angela E. Glenn· Cheryl Clausen
- Observations
- 1
- Pages
- 16
- FEI number
- 3002949099
In short: On February 8, 2019, FDA issued a Form 483 with 1 observation to Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal in Bachupally, India (FEI 3002949099) after an inspection that ran Jan 30 – Feb 8, 2019. The investigators were Angela E. Glenn and Cheryl Clausen. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
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 211.198(a)
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 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). 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 Jan 30 – Feb 8, 2019. 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 Jan 30 – Feb 8, 2019, and the Form 483 is dated February 8, 2019.
How do I get the full Form 483 for Dr. Reddy's Laboratories Ltd. No 41 Bachupally Village & Mandal?
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.