Access Business Group LLC
Form 483 issued June 24, 2022 · Ada, Michigan
- Inspection
- Jun 15 – Jun 24, 2022
- Observations
- 2
- Pages
- 3
- FEI number
- 1000517901
In short: On June 24, 2022, FDA issued a Form 483 with 2 observations to Access Business Group LLC in Ada, Michigan (FEI 1000517901) after an inspection that ran Jun 15 – Jun 24, 2022. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located…
This inspection in context
Questions about this 483
What did FDA find at Access Business Group LLC?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
When was Access Business Group LLC inspected by FDA?
The inspection ran Jun 15 – Jun 24, 2022, and the Form 483 is dated June 24, 2022.
How do I get the full Form 483 for Access Business Group LLC?
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.