Recipharm Pharmaservices Private Limited
Form 483 issued February 1, 2019 · Bengaluru, India
- Inspection
- Jan 28 – Feb 1, 2019
- Investigator
- Marcus A. Ray
- Observations
- 3
- Pages
- 3
- FEI number
- 3009150119
In short: On February 1, 2019, FDA issued a Form 483 with 3 observations to Recipharm Pharmaservices Private Limited in Bengaluru, Karnataka (FEI 3009150119) after an inspection that ran Jan 28 – Feb 1, 2019. The investigator was Marcus A. Ray. Most observations concern production and facilities & equipment.
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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Recipharm Pharmaservices Private Limited?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Recipharm Pharmaservices Private Limited?
Marcus A. Ray is named on this Form 483, for the inspection of Jan 28 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was Recipharm Pharmaservices Private Limited inspected by FDA?
The inspection ran Jan 28 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
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.