Drug factory · FDA FEI 1000522077
Packaging Coordinators, LLC
3001 Red Lion Rd, Philadelphia, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 31, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 31, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 12, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 21, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 6, 2017 | No problems found | Drug Quality Assurance | — |
| Nov 25, 2013 | No problems found | Drug Quality Assurance | — |
| Nov 4, 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.
Jan 31, 2025 inspection
- 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.
Oct 21, 2022 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Registered with FDA for: label; pack; repack; sterilize.