Appco Pharma LLC
FDA inspection history in Piscataway, New Jersey, 2018 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2021: one Form 483; 2022: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Piscataway, New Jersey.
- 2021–24Four Form 483s, at Piscataway, New Jersey.
- 2022The longest 483 on file: 5 observations over 6 pages at Piscataway, New Jersey.
Cited most
Across all Appco Pharma observations on file
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences2
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.166Stability testing1
The complete Appco Pharma file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Piscataway, New Jersey
Five Form 483s · 2018 to 2024 · 13 observations
Latest: Form 483, Mar 11, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-11 | 483 Form 483 | Piscataway, New Jersey | 2 | $99 |
| 2023-08-29 | 483 Form 483 | Piscataway, New Jersey | 3 | $99 |
| 2022-08-19 | 483 Form 483 | Piscataway, New Jersey | 5 | $99 |
| 2021-07-30 | 483 Form 483 | Piscataway, New Jersey | 1 | $99 |
| 2018-11-06 | 483 Form 483 | Piscataway, New Jersey | 2 | $99 |
Investigators on these documents
Alice S. Tsao (1)Ankur C. Patel (1)James R. Birkenstamm (1)Nicholas Violand (1)Tanya R. Syffrard (1)Tyanna N. Hadley (1)
FEI number 3010014758 · most recent document Mar 11, 2024
About Appco Pharma LLC
How many FDA Form 483s has Appco Pharma LLC received?
FDA Intel has 5 Form 483s on file for Appco Pharma LLC; the most recent is dated Mar 11, 2024.
When was Appco Pharma LLC last inspected by FDA?
The most recent FDA inspection document on file for Appco Pharma LLC is a Form 483 dated Mar 11, 2024, for the site in Piscataway, New Jersey.
What did FDA cite at Appco Pharma LLC?
The regulations cited most in the observations on file for Appco Pharma LLC are 21 CFR 211.46 (Ventilation, air filtration, air heating and cooling), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 314.80(b) (Postmarketing reporting of adverse drug experiences), 2 times.