Inspection Record

Hybrid Pharma LLC — FDA 483 Findings

US FDAInspected 2021-09-23Published 2022-05-31 7 findingsRegulatory reporting and change controlLaboratory and QC controlsDeviation, CAPA, and investigationAseptic processing and sterility assurance

Inspectors Jennifer LalamaThe inspectors who signed the published document.Inspector lookup

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Findings

1Regulatory reporting and change control

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).

2Laboratory and QC controls

The accuracy, specificity and reproducibility of test methods have not been established.

3Laboratory and QC controls

You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.

4Laboratory and QC controls

Laboratory records do not include complete data derived from all tests, examinations and assay necessaiy to assure compliance with established specifications and standards.

5Regulatory reporting and change control

Your outsourcing facility did not submit a report to FDA upon initial registration as an outsourcing facility identifying the drugs compounded during the previous six month period.

6Deviation, CAPA, and investigation

Investigations of an unexplained discrepancy did not extend to other batches of the same drng product and other drug products that may have been associated with the specific failure or discrepancy.

7Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2022-05-31. The source is available at the link above.

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.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2023-11-09 · US FDA · 11 findings2016-09-02 · US FDA · 9 findings2022-06-14 · US FDA · 6 findings
Hybrid Pharma LLC company profile — full history US FDA documents, 2022 Go to Findings search