Drug factory · FDA FEI 3015282703
Speciality Pharma Manufacturing, LLC
609 Industrial Road, Carlstadt, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 8, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2020: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydrocortisone | Makes it | Golden State Medical Supply, Inc. | 51407-665 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 8, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Mar 16, 2020 | 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 8, 2025 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. - Homeopathic drugs, assessment of stability 21 CFR 211.166(c)(1)
There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients. - 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 and of adequate size to facilitate operations for its intended use. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Component identity verification 21 CFR 211.84(d)(1)
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Registered with FDA for: manufacture.