OXALIS LABS
Form 483 issued August 2, 2019 · Solan, India
- Inspection
- Jul 29 – Aug 2, 2019
- Investigator
- Jeffrey P. Raimondi
- Observations
- 2
- Pages
- 2
- FEI number
- 3010868532
In short: On August 2, 2019, FDA issued a Form 483 with 2 observations to OXALIS LABS in Solan, Himachal Pradesh (FEI 3010868532) after an inspection that ran Jul 29 – Aug 2, 2019. The investigator was Jeffrey P. Raimondi. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The number of qualified personnel is inadequate to perform the processing…
- 02
Written records are not always made of…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OXALIS LABS?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected OXALIS LABS?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Jul 29 – Aug 2, 2019. Each investigator has a profile showing what they cite most.
When was OXALIS LABS inspected by FDA?
The inspection ran Jul 29 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
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.