Drug factory · FDA FEI 3013495798
Analys Lab Private Limited
Plot No.47, 4th Floor, IDA, Balanagar Medchal Malkajgiri, Medchal Malkajgiri, India
No problems found at FDA's last inspection, Apr 14, 2023.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2018: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Voriconazole | Tests it | Roerig | 0049-3190 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 14, 2023 | No problems found | Drug Quality Assurance | — |
| Dec 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 21, 2018 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Sampling and testing procedures described 21 CFR 211.160(b)(1)
Written specifications for laboratory controls do not include a description of the testing procedures used. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Testing and standardization of standards et. al. 21 CFR 211.194(c)
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards, reagents and standard solutions. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Registered with FDA for: analysis.