Drug factory · FDA FEI 3008816891
A+ Secure Packaging, LLC
339 Mason Rd, La Vergne, TN, United States
No problems found at FDA's last inspection, Jun 7, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Apomorphine | Packages it and labels it | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-004 |
| Botulinum Toxin Type A | Packages it and labels it | Revance Therapeutics, Inc. | 72960-112 |
| Glycerin and Hydroxyethyl Cellulose (5500 Mpa.s At 2%) and Water | Packages it and labels it | Giskit Pharma B.v. | 73254-310 |
| Lofexidine | Packages it and labels it | Prasco Laboratories, Uswm, LLC | 66993-345, 78670-050 |
| Nitisinone | Packages it | Cycle Pharmaceuticals Ltd. | 70709-000, 70709-002, 70709-005 |
| Thiosulfate Ion | Packages it | Fennec Pharmaceuticals Inc. | 73077-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 7, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 16, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 21, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 28, 2011 | Problems found, fixed voluntarily | 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 21, 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. - Specific information required in individual logs 21 CFR 211.182
Individual equipment logs do not show time, date, product, and lot number of each batch processed.
Registered with FDA for: label; pack; relabel; repack.