Elba, Inc.
Form 483 issued October 5, 2017 · Troy, Michigan
- Inspection
- Sep 11 – Oct 5, 2017
- Investigators
- Emilie Kahn· Michelle L. Jones
- Observations
- 5
- Pages
- 11
- FEI number
- 1000115351
In short: On October 5, 2017, FDA issued a Form 483 with 5 observations to Elba, Inc. in Troy, Michigan (FEI 1000115351) after an inspection that ran Sep 11 – Oct 5, 2017. The investigators were Emilie Kahn and Michelle L. Jones. Most observations concern quality system and production.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures are not followed for evaluations done at least annually and including provisions for a…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmElba, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Elba, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Elba, Inc.?
Emilie Kahn and Michelle L. Jones are named on this Form 483, for the inspection of Sep 11 – Oct 5, 2017. Each investigator has a profile showing what they cite most.
When was Elba, Inc. inspected by FDA?
The inspection ran Sep 11 – Oct 5, 2017, and the Form 483 is dated October 5, 2017.
How do I get the full Form 483 for Elba, 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.