Drug factory · FDA FEI 3005485158
Zenara Pharma Private Limited
Plot No. 83/B, 84, 87 to 96, Phase III, IDA Cherlapally, Hyderabad, India
Problems found, fixed voluntarily at FDA's last inspection, May 21, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dichlorphenamide | Makes it, tests it, packages it and labels it | Cycle Pharmaceuticals Ltd., Torrent Pharma, Inc. | 70709-085, 13668-676 |
| Eltrombopag | Makes it | Hikma Pharmaceuticals USA Inc. | 0054-0962, 0054-0963, 0054-0964 +1 |
| Frovatriptan | Makes it, tests it, packages it and labels it | Ingenus Pharmaceuticals, LLC | 50742-299 |
| Methazolamide | Makes it | Precision Dose Inc. | 68094-808, 68094-908 |
| Metolazone | Makes it, tests it, packages it and labels it | Ingenus Pharmaceuticals, LLC | 50742-349, 50742-350, 50742-351 |
| Mexiletine | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 64980-666, 64980-667, 64980-668 |
| Prucalopride | Makes it, tests it, packages it and labels it | Cipla USA., Inc. | 69097-218, 69097-219 |
| Sapropterin | Makes it | Hikma Pharmaceuticals USA Inc. | 0054-0906 |
| Sertraline | Makes it, tests it, packages it and labels it | Cipla USA., Inc. | 69097-438, 69097-451 |
| Vigabatrin | Makes it, tests it, packages it and labels it | Upsher-Smith Laboratories, LLC | 0245-6001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 21, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 21, 2024 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review whether or not the batch has been already distributed. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer are not checked for accuracy.
Registered with FDA for: analysis; label; manufacture; pack.