Hetero Labs Ltd. Unit VI
Form 483 issued September 21, 2023 · Mahabubnagar, India
- Inspection
- Sep 11 – Sep 21, 2023
- Investigators
- Brandy N. Lepage· Jennifer L. Huntington
- Observations
- 8
- Pages
- 11
- FEI number
- 3008294355
In short: On September 21, 2023, FDA issued a Form 483 with 8 observations to Hetero Labs Ltd. Unit VI in Mahabubnagar, Telangana (FEI 3008294355) after an inspection that ran Sep 11 – Sep 21, 2023. The investigators were Brandy N. Lepage and Jennifer L. Huntington. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmHetero Labs Ltd. Unit VI history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Ltd. Unit VI?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Ltd. Unit VI?
Brandy N. Lepage and Jennifer L. Huntington are named on this Form 483, for the inspection of Sep 11 – Sep 21, 2023. Each investigator has a profile showing what they cite most.
When was Hetero Labs Ltd. Unit VI inspected by FDA?
The inspection ran Sep 11 – Sep 21, 2023, and the Form 483 is dated September 21, 2023.
How do I get the full Form 483 for Hetero Labs Ltd. Unit VI?
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