FORDOZ PHARMA CORPORATION
Form 483 issued March 17, 2023 · East Windsor, New Jersey
- Inspection
- Mar 13 – Mar 17, 2023
- Investigators
- Alice S. Tsao· Pushpa S. Jayasekara
- Observations
- 4
- Pages
- 5
- FEI number
- 3012663162
In short: On March 17, 2023, FDA issued a Form 483 with 4 observations to FORDOZ PHARMA CORPORATION in East Windsor, New Jersey (FEI 3012663162) after an inspection that ran Mar 13 – Mar 17, 2023. The investigators were Alice S. Tsao and Pushpa S. Jayasekara. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Observations span 3 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Procedures describing the warehousing of drug products are…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmFORDOZ PHARMA CORPORATION history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FORDOZ PHARMA CORPORATION?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected FORDOZ PHARMA CORPORATION?
Alice S. Tsao and Pushpa S. Jayasekara are named on this Form 483, for the inspection of Mar 13 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was FORDOZ PHARMA CORPORATION inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
How do I get the full Form 483 for FORDOZ PHARMA CORPORATION?
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.