Drug factory · FDA FEI 3009798720
Wickham Micro Limited
Hoeford Point Barwell Lane, Gosport, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Feb 2, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2011: 0 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amikacin | Tests it | Insmed Incorporated | 71558-590 |
| Apomorphine | Tests it | MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. | 27505-004 |
| Buprenorphine | Tests it | Indivior Inc. | 12496-0100, 12496-0300 |
| Selexipag | Tests it | Actelion Pharmaceuticals US, Inc. | 66215-718 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 2, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 27, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 17, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 3, 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.
Feb 17, 2016 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include parameters relevant to the operation. - 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. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the cleaning and sanitizing of equipment.
Registered with FDA for: analysis.