Appco Pharma LLC
Form 483 issued August 29, 2023 · Piscataway, New Jersey
- Inspection
- Aug 21 – Aug 29, 2023
- Investigators
- Alice S. Tsao· Ankur C. Patel
- Observations
- 3
- Pages
- 5
- FEI number
- 3010014758
In short: On August 29, 2023, FDA issued a Form 483 with 3 observations to Appco Pharma LLC in Piscataway, New Jersey (FEI 3010014758) after an inspection that ran Aug 21 – Aug 29, 2023. The investigators were Alice S. Tsao and Ankur C. Patel. Most observations concern facilities & equipment and packaging & labeling.
At a glance
Facilities & equipment and packaging & labeling 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 for adequate control over humidity is not provided when appropriate for the manufacture, processing, packing…
- 02
Procedures describing the warehousing of drug…
- 03
Employees are not given training in the particular operations they perform as…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Appco Pharma LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and quality system. The opening words of each observation are shown on this page.
Who inspected Appco Pharma LLC?
Alice S. Tsao and Ankur C. Patel are named on this Form 483, for the inspection of Aug 21 – Aug 29, 2023. Each investigator has a profile showing what they cite most.
When was Appco Pharma LLC inspected by FDA?
The inspection ran Aug 21 – Aug 29, 2023, and the Form 483 is dated August 29, 2023.
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.