GLAND PHARMA LIMITED — FDA Facility Profile
GLAND PHARMA LIMITED is an FDA-registered facility (FEI 3002647489) located in Hyderabad, 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 25, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (7 VAI, 1 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
- Import refusals
- 9
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 25, 2024 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Record maintenance 1 year (except exempt OTC) (21 CFR 211.180(b)) |
| Jul 14, 2023 | Voluntary Action Indicated (VAI) | Complete test data included in records (21 CFR 211.194(a)) |
| Aug 25, 2022 | Voluntary Action Indicated (VAI) | Design control - no procedures (21 CFR 820.30(a)) |
| May 16, 2019 | Voluntary Action Indicated (VAI) | Product flow through building is inadequate (21 CFR 211.42(b)) Cleaning SOPs/schedules (21 CFR 211.67(b)(2)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Written procedures lacking for use of pesticides etc. (21 CFR 211.56(c)) and 3 more |
| Feb 3, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Mar 17, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 7, 2012 | Voluntary Action Indicated (VAI) | Training , Education , Experience overall (21 CFR 211.25(a)) Protective Apparel Not Worn (21 CFR 211.28(a)) Calibration/Inspection/Checking not done (21 CFR 211.68(a)) Procedures for sterile drug products (21 CFR 211.113(b)) and 7 more |
| Jan 7, 2011 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Gland Pharma Limited
- Location
- Hyderabad (IN)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs