Firm Record

Hybrid Pharma LLC findings history

33 findings from 4 inspection documents published by regulators. Each row below says what its date means.

US FDA 2022-05-31 ~ 2024-01-25 4 documents 33 findings

Areas cited

Aseptic processing and sterility assuranceLaboratory and QC controlsDeviation, CAPA, and investigationTraining and personnelRegulatory reporting and change controlEquipment and facilityOther quality systemDocumentation and recordsValidation and qualificationStability and storageLabeling and packaging

Published inspection documents

2024-01-25 US FDA 11 findingsOther quality system · Equipment and facility · Aseptic processing and sterility assurance · Documentation and records · Regulatory reporting and change control · Laboratory and QC controls Testing and release ofdmg product for distribution do not include appropriate laborato1y dete1mination of satisfact01y conf01mance to the final specifications and identity and strength of each active ingredient prior to release. 2024-01-17 US FDA 9 findingsEquipment and facility · Aseptic processing and sterility assurance · Laboratory and QC controls · Deviation, CAPA, and investigation · Stability and storage · Labeling and packaging · Training and personnel Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper perfo rmance . 2022-06-14 US FDA 6 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Laboratory and QC controls · Training and personnel · Validation and qualification Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a… 2022-05-31 US FDA 7 findingsRegulatory reporting and change control · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance Bulk drug substances used by the outsourcing facility to compound drug products are not manufactured by an establishment that is registered under section 510 as required by section 503B(a)(2)(C).

About this page

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Hybrid Pharma LLC — including inspection classifications Browse by document Go to Findings search