BEL Star S a
Form 483 issued December 13, 2019 · TOCANCIPA, Colombia
- Inspection
- Dec 9 – Dec 13, 2019
- Investigator
- Jason R. Caballero
- Observations
- 4
- Pages
- 4
- FEI number
- 3003840061
In short: On December 13, 2019, FDA issued a Form 483 with 4 observations to BEL Star S a in TOCANCIPA, Cundinamarca (FEI 3003840061) after an inspection that ran Dec 9 – Dec 13, 2019. The investigator was Jason R. Caballero. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
- 03
Manufacturer Employees engaged in the processing of a drug product lack the education and training required…
- 04
Washing and toilet facilities lack…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmBEL Star S a history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BEL Star S a?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected BEL Star S a?
Jason R. Caballero is named on this Form 483, for the inspection of Dec 9 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was BEL Star S a inspected by FDA?
The inspection ran Dec 9 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
How do I get the full Form 483 for BEL Star S a?
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.