Bostal LLC
Form 483 issued April 5, 2023 · Edison, New Jersey
- Inspection
- Mar 22 – Apr 5, 2023
- Investigator
- Daniel J. Min
- Observations
- 2
- Pages
- 3
- FEI number
- 3008953516
In short: On April 5, 2023, FDA issued a Form 483 with 2 observations to Bostal LLC in Edison, New Jersey (FEI 3008953516) after an inspection that ran Mar 22 – Apr 5, 2023. The investigator was Daniel J. Min. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.25(a) (1×) · 211.160(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Employees are not given training in the particular operations they perform as…
- 02
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Daniel J. Min
8 documents · 2021–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBostal LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bostal LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Bostal LLC?
Daniel J. Min is named on this Form 483, for the inspection of Mar 22 – Apr 5, 2023. Each investigator has a profile showing what they cite most.
When was Bostal LLC inspected by FDA?
The inspection ran Mar 22 – Apr 5, 2023, and the Form 483 is dated April 5, 2023.
How do I get the full Form 483 for Bostal 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.