Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27
Form 483 issued October 6, 2023 · HICKSVILLE, New York
- Inspection
- Sep 13 – Oct 6, 2023
- Investigator
- Daniel L. Zheng
- Observations
- 6
- Pages
- 8
- FEI number
- 3001746542
In short: On October 6, 2023, FDA issued a Form 483 with 6 observations to Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 in HICKSVILLE, New York (FEI 3001746542) after an inspection that ran Sep 13 – Oct 6, 2023. The investigator was Daniel L. Zheng. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials 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
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
The quality control unit lacks the responsibility and authority to…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
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 firmApothecus Pharmaceutical Corp. 485 S Broadway Ste 27 history
All 5 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 Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
Daniel L. Zheng is named on this Form 483, for the inspection of Sep 13 – Oct 6, 2023. Each investigator has a profile showing what they cite most.
When was Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 inspected by FDA?
The inspection ran Sep 13 – Oct 6, 2023, and the Form 483 is dated October 6, 2023.
How do I get the full Form 483 for Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
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.