Inventia Healthcare Limited
Form 483 issued July 5, 2019 · Thane, India
- Inspection
- Jul 1 – Jul 5, 2019
- Investigators
- Jose Lopez Rubet· Nicole E. Knowlton
- Observations
- 6
- Pages
- 5
- FEI number
- 3008232264
In short: On July 5, 2019, FDA issued a Form 483 with 6 observations to Inventia Healthcare Limited in Thane, Maharashtra (FEI 3008232264) after an inspection that ran Jul 1 – Jul 5, 2019. The investigators were Jose Lopez Rubet and Nicole E. Knowlton. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory records do not include complete records of the periodic…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Jose Lopez Rubet
5 documents · 2015–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmInventia Healthcare 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 Inventia Healthcare Limited?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Inventia Healthcare Limited?
Jose Lopez Rubet and Nicole E. Knowlton 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 Inventia Healthcare 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 Inventia Healthcare 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.