Drug factory · FDA FEI 1000513101
Pharmaceutics International, Inc.
10819 Gilroy Road, Hunt Valley, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 6, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
14 drug inspections on record since 2009: 1 with no problems, 13 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amifampridine | Makes it and tests it | Catalyst Pharmaceuticals, Inc. | 69616-211 |
| Aprepitant | Tests it | Spes Pharmaceuticals Inc. | 82243-1001 |
| Azathioprine | Makes it | Prometheus Laboratories Inc., Sebela Pharmaceuticals Inc. | 65483-590, 54766-590 |
| Clozapine | Makes it and packages it | TruPharma LLC. | 52817-601 |
| Drospirenone and Ethinyl Estradiol | Makes it and tests it | Pharmaceutics International, Inc. (Pii) | 61916-090 |
| Estradiol and Norethindrone | Makes it | Breckenridge Pharmaceutical, Inc. | 51991-474, 51991-623 |
| Fentanyl | Makes it | Galena Biopharma, Inc. | 57881-331, 57881-332, 57881-333 +3 |
| Penicillamine | Makes it, tests it and packages it | Cycle Pharmaceuticals Ltd. | 70709-102 |
| Spinosad | Makes it, packages it and labels it | ParaPRO LLC | 52246-570, 52246-929 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 6, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 14, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 29, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 10, 2020 | No problems found | Drug Quality Assurance | — |
| Nov 9, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 24, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 18, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 22, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 22, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 25, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 29, 2009 | 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.
Dec 6, 2024 inspection
- 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. - 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. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Registered with FDA for: analysis; manufacture; pack.