Gland Pharma Limited — FDA Facility Profile
Gland Pharma Limited is an FDA-registered facility (FEI 3009056604) located in Visakhapatnam, IN. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jul 28, 2023: No Action Indicated (NAI)
- Inspections on record
- 8 (3 VAI, 5 NAI)
- 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 28, 2023 | No Action Indicated (NAI) | No citations listed |
| Nov 1, 2019 | Voluntary Action Indicated (VAI) | Validation lacking for sterile drug products (21 CFR 211.113(b)) Written record of investigation incomplete (21 CFR 211.192) |
| Jun 15, 2018 | No Action Indicated (NAI) | No citations listed |
| May 18, 2018 | No Action Indicated (NAI) | No citations listed |
| Mar 31, 2017 | No Action Indicated (NAI) | No citations listed |
| Jun 30, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Jun 25, 2015 | No Action Indicated (NAI) | No citations listed |
| Aug 5, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Gland Pharma Limited
- Location
- Visakhapatnam (IN)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs