OXALIS LABS
Form 483 issued June 2, 2023 · Solan, India
- Inspection
- May 29 – Jun 2, 2023
- Investigator
- Teresa I. Navas
- Observations
- 3
- Pages
- 3
- FEI number
- 3010868532
In short: On June 2, 2023, FDA issued a Form 483 with 3 observations to OXALIS LABS in Solan, Himachal Pradesh (FEI 3010868532) after an inspection that ran May 29 – Jun 2, 2023. The investigator was Teresa I. Navas. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
An@@Wrield Alert Report was not submitted within of receipt of information concerning significant chemical, physical, or…
- 03
Routine calibration and inspection of electronic equipment is not performed according to a written program designed…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmOXALIS LABS history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OXALIS LABS?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected OXALIS LABS?
Teresa I. Navas is named on this Form 483, for the inspection of May 29 – Jun 2, 2023. Each investigator has a profile showing what they cite most.
When was OXALIS LABS inspected by FDA?
The inspection ran May 29 – Jun 2, 2023, and the Form 483 is dated June 2, 2023.
How do I get the full Form 483 for OXALIS LABS?
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.