Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27
FDA inspection history across 2 sites, 2019 to 2024
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one close-out letter and one Form 483; 2021: 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.
- 2019–24Four Form 483s and one close-out letter, at Hicksville, New York and HICKSVILLE, New York.
- 2019The longest 483 on file: 7 observations over 9 pages at HICKSVILLE, New York.
Cited most
Across all Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.22(a)Responsibilities of quality control unit3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.125(a)Labeling issuance2
The complete Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
HICKSVILLE, New York
Three Form 483s · 2019 to 2024 · 19 observations
Latest: Form 483, Nov 15, 2024 →Hicksville, New York
One Form 483 and one close-out letter · 2019 to 2021 · 1 observation
Latest: Form 483, May 17, 2021 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-15 | 483 Form 483 | HICKSVILLE, New York | 6 | $99 |
| 2023-10-06 | 483 Form 483 | HICKSVILLE, New York | 6 | $99 |
| 2021-05-17 | 483 Form 483 | Hicksville, New York | 1 | $99 |
| 2019-11-08 | Close-out Close-out letter | Hicksville, New York | — | $99 |
| 2019-04-30 | 483 Form 483 | HICKSVILLE, New York | 7 | $99 |
Investigators on these documents
Bijoy Panicker (1)Brandy N. Lepage (1)Daniel L. Zheng (1)Luxuly Abraham (1)Meredith P. Soehl (1)Paige R. McCoy (1)Sony Mathews (1)
FEI number 3001746542 · most recent document Nov 15, 2024
About Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27
How many FDA Form 483s has Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 received?
FDA Intel has 4 Form 483s on file for Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27; the most recent is dated Nov 15, 2024.
When was Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 last inspected by FDA?
The most recent FDA inspection document on file for Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 is a Form 483 dated Nov 15, 2024, for the site in HICKSVILLE, New York.
What did FDA cite at Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
The regulations cited most in the observations on file for Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.