Drug factory · FDA FEI 3005151016
Strides Pharma Science Limited
Plot No. 101 to 108 & 153, SIDCO Pharmaceutical Complex, Alathur, Chengalpattu, India
Problems found, fixed voluntarily at FDA's last inspection, Apr 5, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 5, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 9, 2019 | No problems found | Drug Quality Assurance | — |
| Nov 25, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 17, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 9, 2009 | No problems found | 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.
Apr 5, 2024 inspection
- Records not made readily available to FDA 21 CFR 211.180(c)
Records associated with drug product and within the retention period for such records, were not made readily available for authorized inspection. Electronic records are used, but they do not meet electronic and human readable copy requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - 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. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Sep 13, 2013 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established standards are not followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; manufacture; pack.