Hetero Labs Limited TSUC Pharma SEZ
Form 483 issued December 16, 2016 · Polepally Village, India
- Inspection
- Dec 7 – Dec 16, 2016
- Investigators
- Latorie S. Jones· Massoud Motamed
- Observations
- 1
- Pages
- 13
- FEI number
- 3008307735
In short: On December 16, 2016, FDA issued a Form 483 with 1 observation to Hetero Labs Limited TSUC Pharma SEZ in Polepally Village, India (FEI 3008307735) after an inspection that ran Dec 7 – Dec 16, 2016. The investigators were Latorie S. Jones and Massoud Motamed. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.180 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmHetero Labs Limited TSUC Pharma SEZ history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited TSUC Pharma SEZ?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited TSUC Pharma SEZ?
Latorie S. Jones and Massoud Motamed are named on this Form 483, for the inspection of Dec 7 – Dec 16, 2016. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited TSUC Pharma SEZ inspected by FDA?
The inspection ran Dec 7 – Dec 16, 2016, and the Form 483 is dated December 16, 2016.
How do I get the full Form 483 for Hetero Labs Limited TSUC Pharma SEZ?
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.