Recipharm Pharmaservices Private Limited
Form 483 issued February 13, 2020 · Bengaluru, India
- Inspection
- Feb 10 – Feb 13, 2020
- Investigator
- Jason R. Caballero
- Observations
- 1
- Pages
- 2
- FEI number
- 3009150119
In short: On February 13, 2020, FDA issued a Form 483 with 1 observation to Recipharm Pharmaservices Private Limited in Bengaluru, Karnataka (FEI 3009150119) after an inspection that ran Feb 10 – Feb 13, 2020. The investigator was Jason R. Caballero. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(a) (1×)
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…
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 firmRecipharm Pharmaservices Private Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Recipharm Pharmaservices Private Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Recipharm Pharmaservices Private Limited?
Jason R. Caballero is named on this Form 483, for the inspection of Feb 10 – Feb 13, 2020. Each investigator has a profile showing what they cite most.
When was Recipharm Pharmaservices Private Limited inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2020, and the Form 483 is dated February 13, 2020.
How do I get the full Form 483 for Recipharm Pharmaservices Private Limited?
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.