Drug factory · FDA FEI 3003978209
Vista Pharmaceuticals Limited
APIIC Industrial Estate, Gopalaipalli Village, , Nalgonda, India
Serious problems, FDA action at FDA's last inspection, Feb 9, 2018.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
3 drug inspections on record since 2009: 0 with no problems, 1 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Sulfamethoxazole and Trimethoprim | Makes it, tests it and packages it | Vista Pharmaceuticals, Inc. | 61971-115, 61971-120 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 9, 2018 | Serious problems, FDA action | Drug Quality Assurance | 10 |
| Sep 23, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| Nov 5, 2009 | 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.
Feb 9, 2018 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - 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 product containers conform to appropriate standards of identity, strength, quality and purity. - Test devices not meeting specifications 21 CFR 211.160(b)(4)
Test devices are deficient in that instruments and gauges not meeting established specifications are 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. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - 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. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training and experience required to perform their assigned functions. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.