Drug factory · FDA FEI 3009056604
Gland Pharma Limited
Unit I & Unit II, Block C, Phase I, Visakhapatnam Special Economic Zone (VSEZ ), Duvvada, Visakhapatnam, India
No problems found at FDA's last inspection, Jul 28, 2023.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2013: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 28, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 15, 2018 | No problems found | Drug Quality Assurance | — |
| May 18, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 25, 2015 | No problems found | Drug Quality Assurance | — |
| Aug 5, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 1, 2019 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.