Biokosmes SRL
FDA inspection history in Lecco, Italy, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Lecco, Italy.
Cited most
Across all Biokosmes SRL observations on file
- 21 CFR 211.101(d)Charge-in of components1
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.188(b)(8)Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Biokosmes SRL file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Lecco, Italy
One Form 483 · 2022 · 9 observations
Latest: Form 483, Dec 2, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-02 | 483 Form 483 | Lecco, Italy | 9 | $99 |
Investigators on these documents
FEI number 3005488444 · most recent document Dec 2, 2022
About Biokosmes SRL
How many FDA Form 483s has Biokosmes SRL received?
FDA Intel has 1 Form 483 on file for Biokosmes SRL; the most recent is dated Dec 2, 2022.
When was Biokosmes SRL last inspected by FDA?
The most recent FDA inspection document on file for Biokosmes SRL is a Form 483 dated Dec 2, 2022, for the site in Lecco, Italy.
What did FDA cite at Biokosmes SRL?
The regulations cited most in the observations on file for Biokosmes SRL are 21 CFR 211.101(d) (Charge-in of components), 1 time; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.