Drug factory · FDA FEI 2246393
EMSL Analytical, Inc. DBA MPL Laboratories
12 Wilson Drive, Sparta, NJ, United States
No problems found at FDA's last inspection, Jan 12, 2024.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2008: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Morphine | Tests it | Nortec Development Associates, Inc. | 42689-005, 42689-006, 42689-007 +3 |
| Phenylbutyric Acid | Tests it | Acer Therapeutics Inc. | 72542-200, 72542-300, 72542-400 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 12, 2024 | No problems found | Drug Quality Assurance | — |
| Oct 3, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 5, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 9, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Oct 20, 2008 | 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.
Sep 18, 2009 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures and laboratory mechanisms are not recorded and justified. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components, in-process materials, and drug products conform to appropriate standards of identity, strength, quality and purity. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness. - 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.
Registered with FDA for: analysis.