Hetero Drugs Limited
Form 483 issued February 14, 2020 · Sangareddy district, India
- Inspection
- Feb 10 – Feb 14, 2020
- Investigators
- Michael Casner· Sneha Patel
- Observations
- 1
- Pages
- 1
- FEI number
- 3003510514
In short: On February 14, 2020, FDA issued a Form 483 with 1 observation to Hetero Drugs Limited in Sangareddy district, Telangana (FEI 3003510514) after an inspection that ran Feb 10 – Feb 14, 2020. The investigators were Michael Casner and Sneha Patel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory control testing of Active Pharmaceutical Ingredients (APIs) for release and stability do not include laboratory…
This inspection in context
Michael Casner
3 documents · 2019–2023
Cites 211.160 (general requirements) 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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Drugs Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hetero Drugs Limited?
Michael Casner and Sneha Patel are named on this Form 483, for the inspection of Feb 10 – Feb 14, 2020. Each investigator has a profile showing what they cite most.
When was Hetero Drugs Limited inspected by FDA?
The inspection ran Feb 10 – Feb 14, 2020, and the Form 483 is dated February 14, 2020.
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.