Drug factory · FDA FEI 1000306996
Sciarra Laboratories, Inc.
Hicksville, New York, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Aug 7, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 7 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Benzocaine | Makes it | Dentsply LLC. Professional Division Trading as "Sultan Healthcare" | 0699-3100 |
| Talc | Makes it, tests it and packages it | Bryan Corp | 63256-100, 63256-200 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 7, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Feb 14, 2018 | No problems found | Drug Quality Assurance | — |
| May 5, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 4, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 7, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 3, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| May 12, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 25, 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.
Aug 7, 2023 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which 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. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not documented at the time of performance. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Jun 3, 2011 inspection
- Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, and holding of the drug product. - 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.