Appco Pharma LLC
Form 483 issued November 6, 2018 · Piscataway, New Jersey
- Inspection
- Nov 6, 2018
- Investigators
- James R. Birkenstamm· Nicholas Violand
- Observations
- 2
- Pages
- 3
- FEI number
- 3010014758
In short: On November 6, 2018, FDA issued a Form 483 with 2 observations to Appco Pharma LLC in Piscataway, New Jersey (FEI 3010014758) after an inspection that ran Nov 6, 2018. The investigators were James R. Birkenstamm and Nicholas Violand. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×) · 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
Equipment used in the manufacture, processing, packing or holding of drug products is not appropriately designed…
- 02
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmAppco Pharma LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Appco Pharma LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Appco Pharma LLC?
James R. Birkenstamm and Nicholas Violand are named on this Form 483, for the inspection of Nov 6, 2018. Each investigator has a profile showing what they cite most.
When was Appco Pharma LLC inspected by FDA?
The inspection ran Nov 6, 2018, and the Form 483 is dated November 6, 2018.
How do I get the full Form 483 for Appco Pharma LLC?
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.