Drug factory · FDA FEI 3011585184
Granules Pharmaceuticals Inc.
3701 & 3725 Concorde Parkway, Chantilly, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 3, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2017: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 3, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Dec 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Aug 3, 2023 | No problems found | Bioresearch Monitoring | — |
| Jul 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 21, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 8, 2017 | 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.
Apr 3, 2026 inspection
- Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - 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. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the holding of a drug product are not maintained in a good state of repair.
Dec 15, 2023 inspection
- 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. - Rejected Material Area 21 CFR 211.42(c)(2)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected components, drug product containers and closures before disposition. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing and holding of a drug product are not maintained in a good state of repair. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.