Par Formulations Private Limited
Form 483 issued April 5, 2022 · Dhar, India
- Inspection
- Mar 29 – Apr 5, 2022
- Investigator
- Saleem A. Akhtar
- Observations
- 3
- Pages
- 5
- FEI number
- 3016268582
In short: On April 5, 2022, FDA issued a Form 483 with 3 observations to Par Formulations Private Limited in Dhar, Madhya Pradesh (FEI 3016268582) after an inspection that ran Mar 29 – Apr 5, 2022. The investigator was Saleem A. Akhtar. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
- 03
Established laboratory control mechanisms…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmPar Formulations Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Par Formulations Private Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Par Formulations Private Limited?
Saleem A. Akhtar is named on this Form 483, for the inspection of Mar 29 – Apr 5, 2022. Each investigator has a profile showing what they cite most.
When was Par Formulations Private Limited inspected by FDA?
The inspection ran Mar 29 – Apr 5, 2022, and the Form 483 is dated April 5, 2022.
How do I get the full Form 483 for Par Formulations 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.