# FDA 483 - Imprimis NJOF, LLC - April 03, 2024

Source: https://www.keypedia.com/records/483/imprimis-njof-llc/5553a4de-00f8-487f-a806-9b12a3d07ea0

> FDA 483 for Imprimis NJOF, LLC on April 03, 2024. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Imprimis NJOF, LLC
- Inspection Date: 2024-04-03
- Office Name: New Jersey District Office
- Summary: The FDA Form 483 details significant deficiencies at a drug manufacturing facility. The firm failed to reject drug products with Out-of-Specification (OOS) stability results, with investigations remaining open despite closed Change Controls to shorten Beyond Use Dates without scientific rationale.

The visual inspection process (SOP# VV-QUAL-06066) is deficient, not requiring investigations for 100% visual inspection failures, even for critical defects. Particulate identification is not required until AQL inspection. Examples include Dexamethasone, Moxifloxacin, and Ketorolac products released after initial 100% visual inspection failures. A Process Verification study for DMK, DM, and Moxifloxacin also showed critical defect failures (fibers, particles) in 100% visual inspection without deviation or investigation.

Confirmatory testing for particles was not conducted for Triamcinolone-Moxifloxacin ICI retain samples linked to increased inflammation complaints, and visual inspectors are not trained on API residue identification. A deviation investigation (QE-0000142) for glass particles found during AQL inspection of DM Lot failed to include an impact and risk analysis for the glass.

Over 1000 complaints for Klarity-Cyclosporine 0.1% (clogged/leaking/empty/underfilled bottles, mold) between 12/2021 and 03

## Related Documents

- [483 - 2017-07-10](https://www.keypedia.com/records/483/imprimis-njof-llc/2e896ba2-f51a-494e-8aa0-6372fb2db81a)
- [WARNING_LETTER - 2017-07-10](https://www.keypedia.com/records/warning_letter/imprimis-njof-llc/204873d0-e82d-4dc7-a000-40345e70bba8)
- [483 - 2021-01-29](https://www.keypedia.com/records/483/imprimis-njof-llc/7653ad75-70c9-493b-a1e6-1a5a482a17e4)

## Related Officers

- [Rose L. Jean-Mary](https://www.keypedia.com/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)
- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.keypedia.com/companies/imprimis-njof-llc/7720fb39-8798-4cfd-9e08-9e0f77adaa2c

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248