Drug factory · FDA FEI 3016088083
Alembic Pharmaceuticals Limited
Formulation Division IV, Halol Road, Jarod, Taluka Waghodia, Vadodara, India
Problems found, fixed voluntarily at FDA's last inspection, Nov 22, 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
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 22, 2024 | 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.
Nov 22, 2024 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and 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. - Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented. - Cleaning SOP/inspection 21 CFR 211.67(b)(6)
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy.
Registered with FDA for: manufacture.