Gland Pharma Limited
Form 483 issued June 30, 2015 · Visakhapatnam, India
- Inspection
- Jun 22 – Jun 30, 2015
- Investigators
- Tamil Arasu· Thomas J. Arista
- Observations
- 12
- Pages
- 7
- FEI number
- 3009056604
In short: On June 30, 2015, FDA issued a Form 483 with 12 observations to Gland Pharma Limited in Visakhapatnam, Andhra Pradesh (FEI 3009056604) after an inspection that ran Jun 22 – Jun 30, 2015. The investigators were Tamil Arasu and Thomas J. Arista. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 9 of 12 observations.
Most cited: 21 CFR 211.113 (5×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ‘Media Fill Validation Protocol” document #AMFV-001 Revision-11 dated 16/05/15 establishes the “purpose of process simulation…
- 02
The following pertains to the (4 Restricted Access Barrier a AB) System (Fill Linelt} ind Fill…
- 03
The gloves used for theyRABS are leak tested per the “Procedure For Operation, Cleaning & Calibration…
- 04
Similar to the glove leak tests equipment, the Administrator for the systems (Manager of Engineering) confirmed…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmGland Pharma Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gland Pharma Limited?
FDA listed 12 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Gland Pharma Limited?
Tamil Arasu and Thomas J. Arista are named on this Form 483, for the inspection of Jun 22 – Jun 30, 2015. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Jun 22 – Jun 30, 2015, and the Form 483 is dated June 30, 2015.
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.