Hetero Drugs Limited
Form 483 issued May 16, 2025 · Sangareddy district, India
- Inspection
- May 12 – May 16, 2025
- Investigator
- Bryan L. McGuckin
- Observations
- 2
- Pages
- 2
- FEI number
- 3003510514
In short: On May 16, 2025, FDA issued a Form 483 with 2 observations to Hetero Drugs Limited in Sangareddy district, Telangana (FEI 3003510514) after an inspection that ran May 12 – May 16, 2025. The investigator was Bryan L. McGuckin. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.165 (1×) · 211.67 (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 laboratory determination of conformance to…
- 02
Procedures for cleaning and maintenance fail to include instructions for the complete removal of…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Drugs Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. 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 Hetero Drugs Limited?
Bryan L. McGuckin is named on this Form 483, for the inspection of May 12 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was Hetero Drugs Limited inspected by FDA?
The inspection ran May 12 – May 16, 2025, and the Form 483 is dated May 16, 2025.
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.