Alivus Life Sciences Limited
Form 483 issued July 5, 2019 · Ankleshwar, India
- Inspection
- Jul 1 – Jul 5, 2019
- Investigators
- O. D. O. Rao· V. A. Rao
- Observations
- 5
- Pages
- 4
- FEI number
- 3004006229
In short: On July 5, 2019, FDA issued a Form 483 with 5 observations to Alivus Life Sciences Limited in Ankleshwar, Gujarat (FEI 3004006229) after an inspection that ran Jul 1 – Jul 5, 2019. The investigators were O. D. O. Rao and V. A. Rao. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specifically, your personnel are not properly trained in their particular job functions and records…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
Specifically, the control systems necessary to prevent contamination…
- 04
The firm failed to conduct a comprehensive investigation to determine the potential impurities detected in…
This inspection in context
O. D. O. Rao
1 document · 2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAlivus Life Sciences Limited history
The site's inspection history, in date order.
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 Alivus Life Sciences Limited?
FDA listed 5 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Alivus Life Sciences Limited?
O. D. O. Rao and V. A. Rao are named on this Form 483, for the inspection of Jul 1 – Jul 5, 2019. Each investigator has a profile showing what they cite most.
When was Alivus Life Sciences Limited inspected by FDA?
The inspection ran Jul 1 – Jul 5, 2019, and the Form 483 is dated July 5, 2019.
How do I get the full Form 483 for Alivus Life Sciences 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.