Drug factory · FDA FEI 3011255967
Apl Healthcare Limited
Unit-3, Sy. No: 410/P, 411/P and 458/P, Plot No. S-1/B, Pharma SEZ, TSIIC, Polepally (Village), Jadcherla (Mandal), Mahabubnagar (District), Mahabubnagar, India
No problems found at FDA's last inspection, Jan 18, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2017: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Adapalene and Benzoyl Peroxide | Makes it and tests it | Aurobindo Pharma Limited | 59651-604 |
| Betamethasone | Makes it and tests it | Aurobindo Pharma Limited, Burel Pharmaceuticals, LLC | 59651-699, 59651-891, 35573-107 |
| Clindamycin | Makes it and tests it | Aurobindo Pharma Limited | 59651-806 |
| Clobetasol | Makes it and tests it | Aurobindo Pharma Limited | 59651-732 |
| Dapsone | Makes it and tests it | Aurobindo Pharma Limited | 59651-666 |
| Econazole | Makes it and tests it | Aurobindo Pharma Limited | 59651-945 |
| Lidocaine | Makes it and tests it | Aurobindo Pharma Limited | 59651-591 |
| Metronidazole | Makes it and tests it | Aurobindo Pharma Limited | 59651-703, 59651-770, 59651-813 |
| Nystatin | Makes it and tests it | Aurobindo Pharma Limited | 59651-907 |
| Permethrin | Makes it and tests it | Aurobindo Pharma Limited | 59651-834, 84386-073 |
| Tretinoin | Makes it and tests it | Aurobindo Pharma Limited | 59651-712, 59651-713 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 18, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 18, 2023 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
| Mar 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 31, 2017 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of associated with a batch of drug product were not maintained at least one (1) year after the expiration date. - Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of associated with a batch of drug product were not maintained at least one (1) year after the expiration date. - Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed. - Investigations made into any unexplained discrepancy 21 CFR 211.188(b)(12)
Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed. - Written sanitation procedures lacking 21 CFR 211.56(b)
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation. - Written sanitation procedures lacking 21 CFR 211.56(b)
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation.
Registered with FDA for: analysis; manufacture.