Dr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72
Form 483 issued June 16, 2017 · Ranashthalam Mandal, India
- Inspection
- Jun 12 – Jun 16, 2017
- Investigators
- Lata Mathew· Stacie Woods
- Observations
- 1
- Pages
- 2
In short: On June 16, 2017, FDA issued a Form 483 with 1 observation to Dr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72 in Ranashthalam Mandal, India after an inspection that ran Jun 12 – Jun 16, 2017. The investigators were Lata Mathew and Stacie Woods. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmDr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Dr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72?
Lata Mathew and Stacie Woods are named on this Form 483, for the inspection of Jun 12 – Jun 16, 2017. Each investigator has a profile showing what they cite most.
When was Dr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72 inspected by FDA?
The inspection ran Jun 12 – Jun 16, 2017, and the Form 483 is dated June 16, 2017.
How do I get the full Form 483 for Dr Reddy's Laboratories Limited FTO-SEZ Unit 1, Surv. 59-60, 62 & 72?
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.