Inopak Ltd
Form 483 issued August 3, 2023 · Ringwood, New Jersey
- Inspection
- Jul 24 – Aug 3, 2023
- Investigators
- Jessica S. Estriplet· Josh Renzo N. Ramilo
- Observations
- 2
- Pages
- 4
- FEI number
- 1000122232
In short: On August 3, 2023, FDA issued a Form 483 with 2 observations to Inopak Ltd in Ringwood, New Jersey (FEI 1000122232) after an inspection that ran Jul 24 – Aug 3, 2023. The investigators were Jessica S. Estriplet and Josh Renzo N. Ramilo. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.22(a) (1×)
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
The quality control unit lacks responsibility for approving or rejecting drug products manufachued and packed under…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmInopak Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Inopak Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Inopak Ltd?
Jessica S. Estriplet and Josh Renzo N. Ramilo are named on this Form 483, for the inspection of Jul 24 – Aug 3, 2023. Each investigator has a profile showing what they cite most.
When was Inopak Ltd inspected by FDA?
The inspection ran Jul 24 – Aug 3, 2023, and the Form 483 is dated August 3, 2023.
How do I get the full Form 483 for Inopak Ltd?
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.