Gland Pharma Limited
Form 483 issued February 3, 2017 · Hyderabad, India
- Inspection
- Jan 23 – Feb 3, 2017
- Investigators
- Ademola O. Daramola· Katherine D. Adams
- Observations
- 2
- Pages
- 5
- FEI number
- 3002647489
In short: On February 3, 2017, FDA issued a Form 483 with 2 observations to Gland Pharma Limited in Hyderabad, Telangana (FEI 3002647489) after an inspection that ran Jan 23 – Feb 3, 2017. The investigators were Ademola O. Daramola and Katherine D. Adams. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.68 (1×)
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
Failure to maintain a backup file of data entered into the computer or related system. Electronic…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmGland Pharma Limited history
All 6 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 2 observations on this Form 483, mostly about production 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?
Ademola O. Daramola and Katherine D. Adams are named on this Form 483, for the inspection of Jan 23 – Feb 3, 2017. Each investigator has a profile showing what they cite most.
When was Gland Pharma Limited inspected by FDA?
The inspection ran Jan 23 – Feb 3, 2017, and the Form 483 is dated February 3, 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.