Par Active Technologies Private Limited
Form 483 issued December 1, 2017 · Alathur, India
- Inspection
- Nov 27 – Dec 1, 2017
- Investigator
- Nadeem I. Chaudhry
- Observations
- 3
- Pages
- 3
- FEI number
- 3003597293
In short: On December 1, 2017, FDA issued a Form 483 with 3 observations to Par Active Technologies Private Limited in Alathur, India (FEI 3003597293) after an inspection that ran Nov 27 – Dec 1, 2017. The investigator was Nadeem I. Chaudhry. Most observations concern facilities & equipment and materials.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of…
- 02
There is a lack of written procedures for assigning responsibility and providing cleaning schedules for…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Nadeem I. Chaudhry
6 documents · 2010–2020
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in India.
The firmPar Active Technologies Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Par Active Technologies Private Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Par Active Technologies Private Limited?
Nadeem I. Chaudhry is named on this Form 483, for the inspection of Nov 27 – Dec 1, 2017. Each investigator has a profile showing what they cite most.
When was Par Active Technologies Private Limited inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2017, and the Form 483 is dated December 1, 2017.
How do I get the full Form 483 for Par Active Technologies Private 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.