Hi-Tech Pharmacal Co. Inc., An AKORN Company
Form 483 issued December 21, 2022 · Amityville, New York
- Inspection
- Nov 28 – Dec 21, 2022
- Investigators
- Daniel L. Zheng· Erik W. Koester
- Observations
- 6
- Pages
- 7
- FEI number
- 2433247
In short: On December 21, 2022, FDA issued a Form 483 with 6 observations to Hi-Tech Pharmacal Co. Inc., An AKORN Company in Amityville, New York (FEI 2433247) after an inspection that ran Nov 28 – Dec 21, 2022. The investigators were Daniel L. Zheng and Erik W. Koester. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Representative samples are not taken of each shipment of each lot of components…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.192
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 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Hi-Tech Pharmacal Co. Inc., An AKORN Company?
Daniel L. Zheng and Erik W. Koester are named on this Form 483, for the inspection of Nov 28 – Dec 21, 2022. 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 Nov 28 – Dec 21, 2022, and the Form 483 is dated December 21, 2022.
How do I get the full Form 483 for Hi-Tech Pharmacal Co. Inc., An AKORN Company?
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