OneSource Specialty Pharma Limited
Form 483 issued August 21, 2013 · Bengaluru, India
- Inspection
- Aug 12 – Aug 21, 2013
- Investigator
- Regina Brown
- Observations
- 4
- Pages
- 2
- FEI number
- 3005652193
In short: On August 21, 2013, FDA issued a Form 483 with 4 observations to OneSource Specialty Pharma Limited in Bengaluru, Karnataka (FEI 3005652193) after an inspection that ran Aug 12 – Aug 21, 2013. The investigator was Regina Brown. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
3 of 4 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
The vial labeling line logbook did not contain entries required by written procedure to show when…
- 02
The()(A)-ontent of mixed waste vials (plugged, unplugged, with (BA witnout(OVTAN removes from the(D)NA fling line area…
- 03
There are activities that are unnecessary that take place…
- 04
The 5/2009 approved process validation ‘or ET secon was performed using a single API batch and…
This inspection in context
Regina Brown
7 documents · 2008–2013
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmOneSource Specialty Pharma Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.182
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OneSource Specialty Pharma Limited?
FDA listed 4 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected OneSource Specialty Pharma Limited?
Regina Brown is named on this Form 483, for the inspection of Aug 12 – Aug 21, 2013. Each investigator has a profile showing what they cite most.
When was OneSource Specialty Pharma Limited inspected by FDA?
The inspection ran Aug 12 – Aug 21, 2013, and the Form 483 is dated August 21, 2013.
How do I get the full Form 483 for OneSource Specialty Pharma 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.