Drug factory · FDA FEI 2243808
Glatt Air Techniques, Inc.
20 Spear Road, Ramsey, NJ, United States
No problems found at FDA's last inspection, Apr 13, 2023.
No Action Indicated: inspectors found no objectionable conditions.
8 drug inspections on record since 2009: 6 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Morphine | Makes it | Nortec Development Associates, Inc. | 42689-005, 42689-006, 42689-007 +3 |
| Phenylbutyric Acid | Makes it | Acer Therapeutics Inc. | 72542-200, 72542-300, 72542-400 +3 |
| Propranolol | Makes it | Nortec Development Associates, Inc. | 42689-011, 42689-012, 42689-013 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 13, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 5, 2018 | No problems found | Drug Quality Assurance | — |
| Jan 19, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 13, 2015 | No problems found | Drug Quality Assurance | — |
| Jan 30, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 4, 2012 | No problems found | Drug Quality Assurance | — |
| Dec 5, 2011 | No problems found | Drug Quality Assurance | — |
| Nov 6, 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.
Jan 19, 2017 inspection
- Quarantine - actual practice 21 CFR 211.142(a)
Drug products are not quarantined before being released by the quality control unit. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; manufacture.