ACS Dobfar SPA
Form 483 issued July 18, 2017 · Tribiano, Italy
- Inspection
- Jan 10 – Jul 18, 2017
- Investigators
- Anastasia M. Shields· Samina S. Khen
- Observations
- 3
- Pages
- 3
- FEI number
- 3002806297
In short: On July 18, 2017, FDA issued a Form 483 with 3 observations to ACS Dobfar SPA in Tribiano, MI (FEI 3002806297) after an inspection that ran Jan 10 – Jul 18, 2017. The investigators were Anastasia M. Shields and Samina S. Khen. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
There are insufficient controls designed to prevent cross…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmACS Dobfar SPA history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ACS Dobfar SPA?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected ACS Dobfar SPA?
Anastasia M. Shields and Samina S. Khen are named on this Form 483, for the inspection of Jan 10 – Jul 18, 2017. Each investigator has a profile showing what they cite most.
When was ACS Dobfar SPA inspected by FDA?
The inspection ran Jan 10 – Jul 18, 2017, and the Form 483 is dated July 18, 2017.
How do I get the full Form 483 for ACS Dobfar SPA?
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.