Drug factory · FDA FEI 1035761
Societal CDMO Gainesville, LLC
1300 Gould Drive, Gainesville, GA, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 19, 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 2010: 5 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrocodone | Makes it | Zogenix, Inc. | 43376-210, 43376-215, 43376-220 +9 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 19, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 24, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jan 31, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 17, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 21, 2010 | No problems found | Drug Quality Assurance | — |
| Mar 24, 2010 | 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.
Nov 19, 2024 inspection
- 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.
Jan 24, 2018 inspection
- 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. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - 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.
Registered with FDA for: analysis; label; manufacture; pack.