Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27
Form 483 issued May 17, 2021 · Hicksville, New York
- Inspection
- Apr 30 – May 17, 2021
- Investigators
- Bijoy Panicker· Brandy N. Lepage
- Observations
- 1
- Pages
- 10
- FEI number
- 3001746542
In short: On May 17, 2021, FDA issued a Form 483 with 1 observation to Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 in Hicksville, New York (FEI 3001746542) after an inspection that ran Apr 30 – May 17, 2021. The investigators were Bijoy Panicker and Brandy N. Lepage. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
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 211.68(b)
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 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
Bijoy Panicker and Brandy N. Lepage are named on this Form 483, for the inspection of Apr 30 – May 17, 2021. 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 Apr 30 – May 17, 2021, and the Form 483 is dated May 17, 2021.
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.