AptaPharma Inc.
FDA inspection history in Pennsauken, New Jersey, 2018 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Pennsauken, New Jersey.
- 2023One Form 483, at Pennsauken, New Jersey.
- 2023The longest 483 on file: 6 observations over 7 pages at Pennsauken, New Jersey.
Cited most
Across all AptaPharma observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.125Labeling issuance1
- 21 CFR 211.142Warehousing procedures1
The complete AptaPharma file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pennsauken, New Jersey
Three Form 483s · 2018 to 2023 · 12 observations
Latest: Form 483, May 15, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-15 | 483 Form 483 | Pennsauken, New Jersey | 6 | $99 |
| 2019-09-25 | 483 Form 483 | Pennsauken, New Jersey | 2 | $99 |
| 2018-03-16 | 483 Form 483 | Pennsauken, New Jersey | 4 | $99 |
Investigators on these documents
Frederick Razzaghi (1)Kristina L. Conroy (1)Nancy M. Espinal (1)
FEI number 3010164738 · most recent document May 15, 2023
About AptaPharma Inc.
How many FDA Form 483s has AptaPharma Inc. received?
FDA Intel has 3 Form 483s on file for AptaPharma Inc.; the most recent is dated May 15, 2023.
When was AptaPharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for AptaPharma Inc. is a Form 483 dated May 15, 2023, for the site in Pennsauken, New Jersey.
What did FDA cite at AptaPharma Inc.?
The regulations cited most in the observations on file for AptaPharma Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.122 (Materials examination and usage criteria), 1 time.