OneSource Specialty Pharma Limited
Form 483 issued September 1, 2015 · Bengaluru, India
- Inspection
- Aug 28 – Sep 1, 2015
- Observations
- 6
- Pages
- 3
- FEI number
- 3005652193
In short: On September 1, 2015, FDA issued a Form 483 with 6 observations to OneSource Specialty Pharma Limited in Bengaluru, Karnataka (FEI 3005652193) after an inspection that ran Aug 28 – Sep 1, 2015. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 6 observations.
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 cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at OneSource Specialty Pharma Limited?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
When was OneSource Specialty Pharma Limited inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2015, and the Form 483 is dated September 1, 2015.
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.