Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27
Form 483 issued November 15, 2024 · HICKSVILLE, New York
- Inspection
- Nov 4 – Nov 15, 2024
- Investigators
- Luxuly Abraham· Paige R. McCoy
- Observations
- 6
- Pages
- 7
- FEI number
- 3001746542
In short: On November 15, 2024, 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 Nov 4 – Nov 15, 2024. The investigators were Luxuly Abraham and Paige R. McCoy. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Strict control is not exercised over labeling issued for use in…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
EIPLOYEE(S) SIGNATURE The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Luxuly Abraham
7 documents · 2023–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.125(a)
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, packaging & labeling and production. The opening words of each observation are shown on this page.
Who inspected Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
Luxuly Abraham and Paige R. McCoy are named on this Form 483, for the inspection of Nov 4 – Nov 15, 2024. 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 Nov 4 – Nov 15, 2024, and the Form 483 is dated November 15, 2024.
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.