Form 483 · FEI 3013722099
Form 483 issued January 25, 2024 · Burligton, Massachusetts
- Investigator
- Erik W. Koester
- Observations
- 1
- Pages
- 5
- FEI number
- 3013722099
In short: On January 25, 2024, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Burligton, Massachusetts (FEI 3013722099). The investigator was Erik W. Koester. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Erik W. Koester is named on this Form 483. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated January 25, 2024.
How do I get the full Form 483 for an FDA-inspected site?
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.