SOFIE Co. dba SOFIE
Form 483 issued August 11, 2023 · Totowa, New Jersey
- Inspection
- Jul 19 – Aug 11, 2023
- Investigator
- Cadre X. Bees
- Observations
- 4
- Pages
- 6
- FEI number
- 3008415560
In short: On August 11, 2023, FDA issued a Form 483 with 4 observations to SOFIE Co. dba SOFIE in Totowa, New Jersey (FEI 3008415560) after an inspection that ran Jul 19 – Aug 11, 2023. The investigator was Cadre X. Bees.
What FDA observed
Preview: the opening words of each observation- 01
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by…
- 0221 CFR 212.80(d)
Labeling and packaging operations for PET drug products were not controlled to prevent…
- 0321 CFR 212.100(b)
Your complaint procedures do not include an investigation to determine the…
- 0421 CFR 212.71(b)
You did not document for a PET drug product that…
This inspection in context
Cadre X. Bees
1 document · 2023
Cites 212.100(b) (what do i do if i receive a complaint about a pet drug product produced at my facility?) more than any other section. Most of their documents are for sites in New Jersey.
The firmSOFIE Co. dba SOFIE history
The site's inspection history, in date order.
Similar 483sOther sites cited under 212.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SOFIE Co. dba SOFIE?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected SOFIE Co. dba SOFIE?
Cadre X. Bees is named on this Form 483, for the inspection of Jul 19 – Aug 11, 2023. Each investigator has a profile showing what they cite most.
When was SOFIE Co. dba SOFIE inspected by FDA?
The inspection ran Jul 19 – Aug 11, 2023, and the Form 483 is dated August 11, 2023.
How do I get the full Form 483 for SOFIE Co. dba SOFIE?
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.