Drug factory · FDA FEI 1000115216
Micro Measurement Laboratories, Inc.
1300 S Wolf Road, Wheeling, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 28, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 4 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pegcetacoplan | Tests it | Apellis Pharmaceuticals, Inc. | 73606-020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 28, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 23, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 27, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 19, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 15, 2012 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2009 | No problems found | Drug Quality Assurance | — |
| Jan 12, 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.
Apr 28, 2026 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable to them. - 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, 2019 inspection
- Acceptance of drug products 21 CFR 211.160(b)(3)
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products. - Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use. - 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.
Jun 27, 2016 inspection
- Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use.
Dec 19, 2013 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. - Lack of or inadequate procedures 21 CFR 820.100(a)
Procedures for corrective and preventive action have not been adequately established. - Quality audits - auditor independence 21 CFR 820.22
Individuals who conduct quality audits have direct responsibility for the matters being audited.
Registered with FDA for: analysis.