Bakelite Chemicals LLC
Form 483 issued November 20, 2019 · Albany, Oregon
- Inspection
- Nov 19 – Nov 20, 2019
- Investigator
- Anita Narula
- Observations
- 3
- Pages
- 4
- FEI number
- 1000126628
In short: On November 20, 2019, FDA issued a Form 483 with 3 observations to Bakelite Chemicals LLC in Albany, Oregon (FEI 1000126628) after an inspection that ran Nov 19 – Nov 20, 2019. The investigator was Anita Narula. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
The batch production and control records are deficient in that they do not include complete labeling…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmBakelite Chemicals LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bakelite Chemicals LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Bakelite Chemicals LLC?
Anita Narula is named on this Form 483, for the inspection of Nov 19 – Nov 20, 2019. Each investigator has a profile showing what they cite most.
When was Bakelite Chemicals LLC inspected by FDA?
The inspection ran Nov 19 – Nov 20, 2019, and the Form 483 is dated November 20, 2019.
How do I get the full Form 483 for Bakelite Chemicals 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.