Hetero Labs Limited
Form 483 issued July 21, 2023 · Hyderabad, India
- Inspection
- Jul 13 – Jul 21, 2023
- Investigators
- Raquel Gonzalez Rivera· Saundrea A. Munroe
- Observations
- 2
- Pages
- 3
- FEI number
- 3005406526
In short: On July 21, 2023, FDA issued a Form 483 with 2 observations to Hetero Labs Limited in Hyderabad, Telangana (FEI 3005406526) after an inspection that ran Jul 13 – Jul 21, 2023. The investigators were Raquel Gonzalez Rivera and Saundrea A. Munroe. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.194(a) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 02
Written records of investigations into unexplained discrepancies do not always include…
This inspection in context
Raquel Gonzalez Rivera
7 documents · 2013–2023
Cites 211.194(a) (laboratory records) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmHetero Labs Limited history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Raquel Gonzalez Rivera and Saundrea A. Munroe are named on this Form 483, for the inspection of Jul 13 – Jul 21, 2023. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
The inspection ran Jul 13 – Jul 21, 2023, and the Form 483 is dated July 21, 2023.
How do I get the full Form 483 for Hetero Labs 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.