Equibal Inc
Form 483 issued May 30, 2024 · Unionville, New York
- Inspection
- May 28 – May 30, 2024
- Investigators
- Ifechimere I. Okafor· Paige R. McCoy· Pushpa S. Jayasekara
- Observations
- 11
- Pages
- 8
- FEI number
- 3003440513
In short: On May 30, 2024, FDA issued a Form 483 with 11 observations to Equibal Inc in Unionville, New York (FEI 3003440513) after an inspection that ran May 28 – May 30, 2024. The investigators were Ifechimere I. Okafor, Paige R. McCoy and Pushpa S. Jayasekara. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Ifechimere I. Okafor
5 documents · 2024–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New York.
The firmEquibal Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Equibal Inc?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Equibal Inc?
Ifechimere I. Okafor, Paige R. McCoy and Pushpa S. Jayasekara are named on this Form 483, for the inspection of May 28 – May 30, 2024. Each investigator has a profile showing what they cite most.
When was Equibal Inc inspected by FDA?
The inspection ran May 28 – May 30, 2024, and the Form 483 is dated May 30, 2024.
How do I get the full Form 483 for Equibal Inc?
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.