Apnar Pharma LLP
Form 483 issued May 14, 2021 · EAST WINDSOR, New Jersey
- Inspection
- May 4 – May 14, 2021
- Investigator
- Monika Borkowska
- Observations
- 3
- Pages
- 3
- FEI number
- 3011136472
In short: On May 14, 2021, FDA issued a Form 483 with 3 observations to Apnar Pharma LLP in EAST WINDSOR, New Jersey (FEI 3011136472) after an inspection that ran May 4 – May 14, 2021. The investigator was Monika Borkowska. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures are lacking which describe in sufficient detail…
This inspection in context
Monika Borkowska
6 documents · 2018–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New Jersey.
The firmApnar Pharma LLP 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 Apnar Pharma LLP?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Apnar Pharma LLP?
Monika Borkowska is named on this Form 483, for the inspection of May 4 – May 14, 2021. Each investigator has a profile showing what they cite most.
When was Apnar Pharma LLP inspected by FDA?
The inspection ran May 4 – May 14, 2021, and the Form 483 is dated May 14, 2021.
How do I get the full Form 483 for Apnar Pharma LLP?
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.