Drug factory · FDA FEI 1000121692
LTS Lohmann Therapy Systems Corp.
21 Henderson Drive, West Caldwell, NJ, United States
No problems found at FDA's last inspection, Feb 1, 2024.
No Action Indicated: inspectors found no objectionable conditions.
9 drug inspections on record since 2009: 5 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine | Makes it | Knoa Pharma LLC, Rhodes Pharmaceuticals L.P. | 59011-750, 59011-751, 59011-752 +7 |
| Buprenorphine and Naloxone | Makes it and tests it | Dr. Reddy's Laboratories Inc. | 43598-579, 43598-580, 43598-581 +1 |
| Fentanyl | Makes it and tests it | SpecGx LLC | 0406-9037, 0406-9062, 0406-9100 +4 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 1, 2024 | No problems found | Drug Quality Assurance | — |
| Jun 11, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 21, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 7, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 25, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 11, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 17, 2010 | No problems found | Drug Quality Assurance | — |
| Apr 27, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 11, 2019 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Sep 11, 2012 inspection
- Individual inventory record 21 CFR 211.184(c)
Records fail to include an individual inventory record of each component, reconciliation of the use of each component, drug product container, and drug product closure with sufficient information to allow determination of any associated batch or lot of drug product. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic equipment is not performed according to a written program designed to assure proper performance.
Apr 27, 2009 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified. - 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.
Registered with FDA for: analysis; manufacture; pack.