Gland Pharma Limited
Form 483 issued March 31, 2017 · Visakhapatnam, India
- Observations
- 4
- Pages
- 3
- FEI number
- 3009056604
In short: On March 31, 2017, FDA issued a Form 483 with 4 observations to Gland Pharma Limited in Visakhapatnam, Andhra Pradesh (FEI 3009056604). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Routine checking of automatic equipment is not performed according to a written program designed…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Questions about this 483
What did FDA find at Gland Pharma Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Gland Pharma Limited inspected by FDA?
This Form 483 is dated March 31, 2017.
How do I get the full Form 483 for Gland 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.