Hetero Drugs Limited
Form 483 issued March 2, 2018 · Mandal, India
- Inspection
- Feb 26 – Mar 2, 2018
- Investigator
- Yvins Dezan
- Observations
- 3
- Pages
- 3
- FEI number
- 3003510514
In short: On March 2, 2018, FDA issued a Form 483 with 3 observations to Hetero Drugs Limited in Mandal, India (FEI 3003510514) after an inspection that ran Feb 26 – Mar 2, 2018. The investigator was Yvins Dezan. Most observations concern quality system.
At a glance
3 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Employees engaged in the processing, holding, and testing of a drug product lack…
This inspection in context
Yvins Dezan
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHetero Drugs 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Drugs Limited?
FDA listed 3 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Hetero Drugs Limited?
Yvins Dezan is named on this Form 483, for the inspection of Feb 26 – Mar 2, 2018. Each investigator has a profile showing what they cite most.
When was Hetero Drugs Limited inspected by FDA?
The inspection ran Feb 26 – Mar 2, 2018, and the Form 483 is dated March 2, 2018.
How do I get the full Form 483 for Hetero Drugs 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.