Drug factory · FDA FEI 3003053502
Unique Pharmaceutical Laboratories
Plot No. 215-219, G.I.D.C Industrial Area, Bharuch, India
Problems found, fixed voluntarily at FDA's last inspection, Oct 23, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 23, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 7, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jun 24, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 18, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 2, 2011 | No problems found | 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.
Feb 7, 2020 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Aug 24, 2018 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch.
Registered with FDA for: analysis; manufacture; pack.