Biokosmes SRL
Form 483 issued December 2, 2022 · Lecco, Italy
- Inspection
- Nov 28 – Dec 2, 2022
- Investigator
- Nicole E. Knowlton
- Observations
- 9
- Pages
- 4
- FEI number
- 3005488444
In short: On December 2, 2022, FDA issued a Form 483 with 9 observations to Biokosmes SRL in Lecco, Italy (FEI 3005488444) after an inspection that ran Nov 28 – Dec 2, 2022. The investigator was Nicole E. Knowlton. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmBiokosmes SRL history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biokosmes SRL?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Biokosmes SRL?
Nicole E. Knowlton is named on this Form 483, for the inspection of Nov 28 – Dec 2, 2022. Each investigator has a profile showing what they cite most.
When was Biokosmes SRL inspected by FDA?
The inspection ran Nov 28 – Dec 2, 2022, and the Form 483 is dated December 2, 2022.
How do I get the full Form 483 for Biokosmes SRL?
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.