Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27
Form 483 issued April 30, 2019 · HICKSVILLE, New York
- Inspection
- Apr 30, 2019
- Investigators
- Meredith P. Soehl· Sony Mathews
- Observations
- 7
- Pages
- 9
- FEI number
- 3001746542
In short: On April 30, 2019, FDA issued a Form 483 with 7 observations to Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27 in HICKSVILLE, New York (FEI 3001746542) after an inspection that ran Apr 30, 2019. The investigators were Meredith P. Soehl and Sony Mathews. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Meredith P. Soehl
4 documents · 2009–2019
Cites 110.80(a)(4) (processes and controls) 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 211.165
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 7 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Apothecus Pharmaceutical Corp. 485 S Broadway Ste 27?
Meredith P. Soehl and Sony Mathews are named on this Form 483, for the inspection of Apr 30, 2019. 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, 2019, and the Form 483 is dated April 30, 2019.
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.