DR. REDDY'S Laboratories LIMITED
Form 483 issued March 5, 2020 · Nalgonda, India
- Inspection
- Mar 1 – Mar 5, 2020
- Investigators
- Christopher Keating· Tomika L. Reaves
- Observations
- 3
- Pages
- 2
- FEI number
- 3005447965
In short: On March 5, 2020, FDA issued a Form 483 with 3 observations to DR. REDDY'S Laboratories LIMITED in Nalgonda, Telangana (FEI 3005447965) after an inspection that ran Mar 1 – Mar 5, 2020. The investigators were Christopher Keating and Tomika L. Reaves. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your system for reprocess ing of A Pis and API…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Christopher Keating
13 documents · 2018–2020
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
All 3 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 LIMITED?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. 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 LIMITED?
Christopher Keating and Tomika L. Reaves are named on this Form 483, for the inspection of Mar 1 – Mar 5, 2020. Each investigator has a profile showing what they cite most.
When was DR. REDDY'S Laboratories LIMITED inspected by FDA?
The inspection ran Mar 1 – Mar 5, 2020, and the Form 483 is dated March 5, 2020.
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.