Hi-Tech Pharmacal Co. Inc., An AKORN Company
Form 483 issued July 15, 2016 · Amityville, New York
- Inspection
- Jul 6 – Jul 15, 2016
- Investigators
- Alice S. Tsao· Helen B. Ricalde· Marie B. Buen-Bigornia
- Observations
- 1
- Pages
- 1
- FEI number
- 2433247
In short: On July 15, 2016, FDA issued a Form 483 with 1 observation to Hi-Tech Pharmacal Co. Inc., An AKORN Company in Amityville, New York (FEI 2433247) after an inspection that ran Jul 6 – Jul 15, 2016. The investigators were Alice S. Tsao, Helen B. Ricalde, Marie B. Buen-Bigornia, Mindy M. Chou, Robert C. Steyert and Sony Mathews. Most observations concern production; the most-cited regulation is 21 CFR 211.111 (time limitations on production).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.111 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.111
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.111 (time limitations on production). The opening words of each observation are shown on this page.
Who inspected Hi-Tech Pharmacal Co. Inc., An AKORN Company?
Alice S. Tsao, Helen B. Ricalde, Marie B. Buen-Bigornia, Mindy M. Chou, Robert C. Steyert and Sony Mathews are named on this Form 483, for the inspection of Jul 6 – Jul 15, 2016. 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 Jul 6 – Jul 15, 2016, and the Form 483 is dated July 15, 2016.
How do I get the full Form 483 for Hi-Tech Pharmacal Co. Inc., An AKORN Company?
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