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GLAND PHARMA LIMITED — FDA Facility Profile

FEI 3009864167

GLAND PHARMA LIMITED is an FDA-registered facility (FEI 3009864167) located in Hyderabad, IN. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Aug 26, 2023: Voluntary Action Indicated (VAI)
Inspections on record
5 (5 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents
1 in FDA's reading room

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 26, 2023Voluntary Action Indicated (VAI)QSR (21 CFR 820.186)
Equipment Installation, Placement, Specified Requirements (21 CFR 820.70(g))
Jun 27, 2023Voluntary Action Indicated (VAI)No citations listed
Nov 7, 2019Voluntary Action Indicated (VAI)Representative Samples (21 CFR 211.84(b))
Equipment for Environmental Control (21 CFR 211.46(b))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Written record of investigation incomplete (21 CFR 211.192)
Feb 23, 2018Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Procedures for sterile drug products (21 CFR 211.113(b))
In-process conformity - examination, sample testing (21 CFR 211.110(b))
Complaint Handling Procedure (21 CFR 211.198(a))
Sep 18, 2015Voluntary Action Indicated (VAI)No citations listed

Form 483s and inspection documents

Facility details

Company
Gland Pharma Limited
Location
Hyderabad (IN)
Registration Expires
Dec 31, 2027
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.