Drug factory · FDA FEI 3008127341
Sidmak Laboratories (India) Private Limited
Plot No. 20, Pharma City, Selaqui Industrial Area, Vikas Nagar, Dehradun - 248011, Uttarakhand, India, Dehradun, India
No problems found at FDA's last inspection, May 13, 2023.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2012: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fluoxetine | Makes it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-028, 23155-029, 23155-030 |
| Modafinil | Makes it, tests it and packages it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-604, 23155-605, 23155-862 |
| Nitrofurantoin | Makes it | BluePoint Laboratories., Caraco Pharmaceutical Laboratories, Ltd. | 68001-384, 68001-385, 68001-386 +3 |
| Sertraline | Makes it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-757, 23155-758, 23155-759 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 13, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 14, 2020 | No problems found | Drug Quality Assurance | — |
| Mar 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jun 6, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 26, 2012 | 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.
Mar 31, 2017 inspection
- Sampling/testing of labeling/packaging materials 21 CFR 211.122(a)
Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in packaging and labeling of a drug product. - 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. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies. - 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.
Registered with FDA for: analysis; manufacture; pack.