Apozeal Pharmaceuticals Inc.
FDA inspection history across 2 sites, 2019
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2019: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter and one Form 483, at Basking Ridge, New Jersey and Levittown, Pennsylvania.
Cited most
Across all Apozeal Pharmaceuticals observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.110(b)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.160(b)(3)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Apozeal Pharmaceuticals file.
All 2 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
Basking Ridge, New Jersey
One close-out letter · 2019
Latest: Close-out, Oct 28, 2019 →Levittown, Pennsylvania
One Form 483 · 2019 · 8 observations
Latest: Form 483, Apr 9, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-28 | Close-out Close-out letter | Basking Ridge, New Jersey | — | $99 |
| 2019-04-09 | 483 Form 483 | Levittown, Pennsylvania | 8 | $99 |
Investigators on these documents
FEI number 3004536846 · most recent document Oct 28, 2019
About Apozeal Pharmaceuticals Inc.
How many FDA Form 483s has Apozeal Pharmaceuticals Inc. received?
FDA Intel has 1 Form 483 on file for Apozeal Pharmaceuticals Inc.; the most recent is dated Apr 9, 2019.
When was Apozeal Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Apozeal Pharmaceuticals Inc. is a Form 483 dated Apr 9, 2019, for the site in Levittown, Pennsylvania.
What did FDA cite at Apozeal Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Apozeal Pharmaceuticals Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.110(b) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.