Innovation Labs, Inc.
Form 483 issued July 5, 2022 · Mahwah, New Jersey
- Inspection
- Jun 21 – Jul 5, 2022
- Investigator
- Jogy George
- Observations
- 4
- Pages
- 5
- FEI number
- 3015300984
In short: On July 5, 2022, FDA issued a Form 483 with 4 observations to Innovation Labs, Inc. in Mahwah, New Jersey (FEI 3015300984) after an inspection that ran Jun 21 – Jul 5, 2022. The investigator was Jogy George. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained. in…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Jogy George
15 documents · 2016–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmInnovation Labs, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovation Labs, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Innovation Labs, Inc.?
Jogy George is named on this Form 483, for the inspection of Jun 21 – Jul 5, 2022. Each investigator has a profile showing what they cite most.
When was Innovation Labs, Inc. inspected by FDA?
The inspection ran Jun 21 – Jul 5, 2022, and the Form 483 is dated July 5, 2022.
How do I get the full Form 483 for Innovation Labs, Inc.?
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.