Cilag AG
Form 483 issued July 16, 2019 · Schaffhausen, Switzerland
- Inspection
- Jul 8 – Jul 16, 2019
- Investigator
- Santos E. Camara
- Observations
- 4
- Pages
- 3
- FEI number
- 3002806695
In short: On July 16, 2019, FDA issued a Form 483 with 4 observations to Cilag AG in Schaffhausen, Switzerland (FEI 3002806695) after an inspection that ran Jul 8 – Jul 16, 2019. The investigator was Santos E. Camara. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 02
Established test procedures are…
- 03
Laboratory records do not include complete records of the periodic…
- 04
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmCilag AG history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cilag AG?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Cilag AG?
Santos E. Camara is named on this Form 483, for the inspection of Jul 8 – Jul 16, 2019. Each investigator has a profile showing what they cite most.
When was Cilag AG inspected by FDA?
The inspection ran Jul 8 – Jul 16, 2019, and the Form 483 is dated July 16, 2019.
How do I get the full Form 483 for Cilag AG?
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.