Drug factory · FDA FEI 3003612465
Pine Lake Investments, Inc.
719 Middle St, Bristol, CT, United States
No problems found at FDA's last inspection, Jul 1, 2026.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Methadone | Tests it | Breckenridge Pharmaceutical, Inc. | 51991-002 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 1, 2026 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2021 | No problems found | Drug Quality Assurance | — |
| Mar 8, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 28, 2011 | No problems found | Drug Quality Assurance | — |
| Mar 18, 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.
Mar 8, 2016 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components , drug product containers , closures , in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning and maintenance are not included in individual equipment logs. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Registered with FDA for: analysis.