Hi-Tech Pharmacal Co. Inc., An AKORN Company
Form 483 issued February 13, 2019 · Amityville, New York
- Inspection
- Jan 23 – Feb 13, 2019
- Investigator
- Jay T. Wong
- Observations
- 4
- Pages
- 4
- FEI number
- 2433247
In short: On February 13, 2019, FDA issued a Form 483 with 4 observations to Hi-Tech Pharmacal Co. Inc., An AKORN Company in Amityville, New York (FEI 2433247) after an inspection that ran Jan 23 – Feb 13, 2019. The investigator was Jay T. Wong. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Records are not kept for the maintenance, cleaning, sanitizing…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Human Sterile and Non-Sterile Drug Manufacturer The written stability testing…
- 04
Containers and closures are not tested for conformance with…
This inspection in context
Jay T. Wong
5 documents · 2019–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmHi-Tech Pharmacal Co. Inc., An AKORN Company history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hi-Tech Pharmacal Co. Inc., An AKORN Company?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Hi-Tech Pharmacal Co. Inc., An AKORN Company?
Jay T. Wong is named on this Form 483, for the inspection of Jan 23 – Feb 13, 2019. Each investigator has a profile showing what they cite most.
When was Hi-Tech Pharmacal Co. Inc., An AKORN Company inspected by FDA?
The inspection ran Jan 23 – Feb 13, 2019, and the Form 483 is dated February 13, 2019.
How do I get the full Form 483 for Hi-Tech Pharmacal Co. Inc., An AKORN Company?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.