FDA Inspection
Hetero Drugs Ltd. - Unit 1Hetero Drugs Ltd. - Unit 1 – FDA Inspection, Mar 2, 2018
Record Details
This FDA Inspection record concerns Hetero Drugs Ltd. - Unit 1, with an inspection on March 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 75379504-1534-4c90-a4f5-60c8f64105c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044698
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Hetero Drugs Ltd. - Unit 1
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2025 | Not classified | Office of Inspections and Investigations | |
| February 14, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 25, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 2, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 11, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hetero Drugs Ltd. - Unit 1
- FDA Inspection 1269555 - 2025-05-16
- FDA Inspection 1121294 - 2020-02-14
- FDA Inspection 963050 - 2016-02-25
- FDA Inspection 888747 - 2014-05-02
- FDA Inspection 700761 - 2010-11-11
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.