Bora Pharmaceuticals Injectables Inc.
Form 483 issued August 27, 2010 · Baltimore, Maryland
- Observations
- 7
- Pages
- 2
- FEI number
- 1000512361
In short: On August 27, 2010, FDA issued a Form 483 with 7 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure of the Quality Assurance unit to thoroughly review any unexplained discre ancy…
- 02
The certification program used to qualify inspectors involved in the visual inspection process for filled syringes…
- 03
During filling operations, doors connecting rooms 118 to Gowning room Rod Tray Loading room 104A…
- 04
During set-up procedures within a Class 100 aseptic filling area, operators were…
This inspection in context
Questions about this 483
What did FDA find at Bora Pharmaceuticals Injectables Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
This Form 483 is dated August 27, 2010.
How do I get the full Form 483 for Bora Pharmaceuticals Injectables Inc.?
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.