SOFIE Co. dba SOFIE
FDA inspection history in Totowa, New Jersey, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Totowa, New Jersey.
Cited most
Across all SOFIE Co. dba SOFIE observations on file
- 21 CFR 212.100(b)What do I do if I receive a complaint about a PET drug product produced at my facility?1
- 21 CFR 212.30(a)What requirements must my facilities and equipment meet?1
- 21 CFR 212.71(b)What actions must I take if a batch of PET drug product does not conform to specifications?1
- 21 CFR 212.80(d)What are the requirements associated with labeling and packaging PET drug products?1
The complete SOFIE Co. dba SOFIE file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Totowa, New Jersey
One Form 483 · 2023 · 4 observations
Latest: Form 483, Aug 11, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-11 | 483 Form 483 | Totowa, New Jersey | 4 | $99 |
Investigators on these documents
FEI number 3008415560 · most recent document Aug 11, 2023
About SOFIE Co. dba SOFIE
How many FDA Form 483s has SOFIE Co. dba SOFIE received?
FDA Intel has 1 Form 483 on file for SOFIE Co. dba SOFIE; the most recent is dated Aug 11, 2023.
When was SOFIE Co. dba SOFIE last inspected by FDA?
The most recent FDA inspection document on file for SOFIE Co. dba SOFIE is a Form 483 dated Aug 11, 2023, for the site in Totowa, New Jersey.
What did FDA cite at SOFIE Co. dba SOFIE?
The regulations cited most in the observations on file for SOFIE Co. dba SOFIE are 21 CFR 212.100(b) (What do I do if I receive a complaint about a PET drug product produced at my facility?), 1 time; 21 CFR 212.30(a) (What requirements must my facilities and equipment meet?), 1 time; 21 CFR 212.71(b) (What actions must I take if a batch of PET drug product does not conform to specifications?), 1 time.