Hi-Tech Pharmacal Co. Inc., An AKORN Company
Form 483 issued July 20, 2015 · Amityville, New York
- Inspection
- Jun 24 – Jul 20, 2015
- Investigators
- Felix Maldonado· Robert C. Steyert
- Observations
- 3
- Pages
- 2
- FEI number
- 2433247
In short: On July 20, 2015, FDA issued a Form 483 with 3 observations to Hi-Tech Pharmacal Co. Inc., An AKORN Company in Amityville, New York (FEI 2433247) after an inspection that ran Jun 24 – Jul 20, 2015. The investigators were Felix Maldonado and Robert C. Steyert. Most observations concern laboratory controls and production.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established standards, specifications, and quality control…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Felix Maldonado
6 documents · 2009–2019
Cites 211.160 (general requirements) 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 211.165(f)
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 3 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Hi-Tech Pharmacal Co. Inc., An AKORN Company?
Felix Maldonado and Robert C. Steyert are named on this Form 483, for the inspection of Jun 24 – Jul 20, 2015. 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 Jun 24 – Jul 20, 2015, and the Form 483 is dated July 20, 2015.
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.