Drug factory · FDA FEI 2434223
Strides Pharma, Inc
1 Ram Ridge Rd, Chestnut Ridge, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 8, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2009: 4 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 8, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 23, 2019 | No problems found | Bioresearch Monitoring | — |
| Jun 5, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 4, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 19, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 4, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 4, 2012 | No problems found | Bioresearch Monitoring | — |
| May 4, 2011 | No problems found | Drug Quality Assurance | — |
| Aug 7, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 19, 2013 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - 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. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Aug 7, 2009 inspection
- In-process materials characteristics testing 21 CFR 211.110(c)
In-process materials are not tested for quality and purity and approved or rejected by the quality control unit after storage for long periods. - 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. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; manufacture; pack.