Betco Corporation, Ltd.
Form 483 issued April 17, 2025 · Bowling Green, Ohio
- Investigator
- Ngozi G. Offor
- Observations
- 4
- Pages
- 17
- FEI number
- 1000638666
In short: On April 17, 2025, FDA issued a Form 483 with 4 observations to Betco Corporation, Ltd. in Bowling Green, Ohio (FEI 1000638666). The investigator was Ngozi G. Offor. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
GMP training is not conducted to assure that employees remain familiar with CGMP…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
This inspection in context
Ngozi G. Offor
4 documents · 2025–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmBetco Corporation, Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Betco Corporation, Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Betco Corporation, Ltd.?
Ngozi G. Offor is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Betco Corporation, Ltd. inspected by FDA?
This Form 483 is dated April 17, 2025.
How do I get the full Form 483 for Betco Corporation, Ltd.?
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.