Appco Pharma LLC
Form 483 issued August 19, 2022 · Piscataway, New Jersey
- Inspection
- Aug 8 – Aug 19, 2022
- Investigator
- Tanya R. Syffrard
- Observations
- 5
- Pages
- 6
- FEI number
- 3010014758
In short: On August 19, 2022, FDA issued a Form 483 with 5 observations to Appco Pharma LLC in Piscataway, New Jersey (FEI 3010014758) after an inspection that ran Aug 8 – Aug 19, 2022. The investigator was Tanya R. Syffrard. Most observations concern facilities & equipment and laboratory controls.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not describe the storage conditions for…
- 02
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Tanya R. Syffrard
11 documents · 2021–2025
Cites 211.166 (stability testing) 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Appco Pharma LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Appco Pharma LLC?
Tanya R. Syffrard is named on this Form 483, for the inspection of Aug 8 – Aug 19, 2022. Each investigator has a profile showing what they cite most.
When was Appco Pharma LLC inspected by FDA?
The inspection ran Aug 8 – Aug 19, 2022, and the Form 483 is dated August 19, 2022.
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.