Haney Inc
Form 483 issued October 18, 2022 · Cincinnati, Ohio
- Inspection
- Oct 12 – Oct 18, 2022
- Investigators
- Rafeeq Habeeb· Wen Ning Chan
- Observations
- 4
- Pages
- 4
- FEI number
- 3007353165
In short: On October 18, 2022, FDA issued a Form 483 with 4 observations to Haney Inc in Cincinnati, Ohio (FEI 3007353165) after an inspection that ran Oct 12 – Oct 18, 2022. The investigators were Rafeeq Habeeb and Wen Ning Chan. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
Written production and process control procedures are not followed in the execution of production…
- 03
The batch production and control records are deficient in that they do not include of components…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Rafeeq Habeeb
20 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHaney Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Haney Inc?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Haney Inc?
Rafeeq Habeeb and Wen Ning Chan are named on this Form 483, for the inspection of Oct 12 – Oct 18, 2022. Each investigator has a profile showing what they cite most.
When was Haney Inc inspected by FDA?
The inspection ran Oct 12 – Oct 18, 2022, and the Form 483 is dated October 18, 2022.
How do I get the full Form 483 for Haney 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.