Apnar Pharma Private Limited
Form 483 issued September 16, 2022 · Vadodara, India
- Inspection
- Sep 12 – Sep 16, 2022
- Investigator
- Joel D. Hustedt
- Observations
- 1
- Pages
- 1
- FEI number
- 3016579947
In short: On September 16, 2022, FDA issued a Form 483 with 1 observation to Apnar Pharma Private Limited in Vadodara, Gujarat (FEI 3016579947) after an inspection that ran Sep 12 – Sep 16, 2022. The investigator was Joel D. Hustedt. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmApnar Pharma Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apnar Pharma Private Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Apnar Pharma Private Limited?
Joel D. Hustedt is named on this Form 483, for the inspection of Sep 12 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Apnar Pharma Private Limited inspected by FDA?
The inspection ran Sep 12 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
How do I get the full Form 483 for Apnar Pharma 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.