Hi-Tech Pharmacal Co. Inc., An AKORN Company
FDA inspection history in Amityville, New York, 2015 to 2022
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483; 2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, at Amityville, New York.
- 2019One Form 483, at Amityville, New York.
- 2022One Form 483, at Amityville, New York.
- 2022The longest 483 on file: 6 observations over 7 pages at Amityville, New York.
Cited most
Across all Hi-Tech Pharmacal Co. Inc., An AKORN observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.111Time limitations on production1
The complete Hi-Tech Pharmacal Co. Inc., An AKORN file.
All 4 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
Amityville, New York
Four Form 483s · 2015 to 2022 · 14 observations
Latest: Form 483, Dec 21, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-21 | 483 Form 483 | Amityville, New York | 6 | $99 |
| 2019-02-13 | 483 Form 483 | Amityville, New York | 4 | $99 |
| 2016-07-15 | 483 Form 483 | Amityville, New York | 1 | $99 |
| 2015-07-20 | 483 Form 483 | Amityville, New York | 3 | $99 |
Investigators on these documents
Robert C. Steyert (2)Daniel L. Zheng (1)Erik W. Koester (1)Felix Maldonado (1)Helen B. Ricalde (1)Jay T. Wong (1)Marie B. Buen-Bigornia (1)Mindy M. Chou (1)Alice S. Tsao (1)Sony Mathews (1)
FEI number 2433247 · most recent document Dec 21, 2022
About Hi-Tech Pharmacal Co. Inc., An AKORN Company
How many FDA Form 483s has Hi-Tech Pharmacal Co. Inc., An AKORN Company received?
FDA Intel has 4 Form 483s on file for Hi-Tech Pharmacal Co. Inc., An AKORN Company; the most recent is dated Dec 21, 2022.
When was Hi-Tech Pharmacal Co. Inc., An AKORN Company last inspected by FDA?
The most recent FDA inspection document on file for Hi-Tech Pharmacal Co. Inc., An AKORN Company is a Form 483 dated Dec 21, 2022, for the site in Amityville, New York.
What did FDA cite at Hi-Tech Pharmacal Co. Inc., An AKORN Company?
The regulations cited most in the observations on file for Hi-Tech Pharmacal Co. Inc., An AKORN Company are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.84(b) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time.