# FDA EIR - Akorn Operating Company LLC - May 12, 2017

Source: https://www.keypedia.com/records/eir/akorn-operating-company-llc/03ebbaf3-cbc1-46af-989d-25673b975c3b

> FDA EIR for Akorn Operating Company LLC on May 12, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Akorn Operating Company LLC
- Inspection Date: 2017-05-12
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: An FDA surveillance and pre-approval inspection of Akominc. in Somerset, NJ, was conducted from May 2 to May 12, 2017. The inspection covered Good Manufacturing Practices (GMP) and pre-approval requirements for sterile drug products, including solutions, ointments, and jellies, following regulatory guidelines such as CP7356.002A. During this inspection, no new objectionable conditions or GMP deficiencies were noted, and no FDA-483 Inspectional Observations were issued. This positive outcome followed a previous inspection in April 2016, which resulted in a 12-item FDA-483 citing multiple GMP deficiencies. These prior issues included failures in aseptic technique, inadequate investigation processes, deficiencies in the stability testing program, poor documentation practices, unrepresentative media fills and smoke studies, unauthorized changes to validation protocols, and incomplete method verifications and transfers. Akominc. implemented comprehensive corrective actions addressing each of these previous observations, such as updating Standard Operating Procedures, conducting extensive personnel retraining on aseptic practices and documentation, and enhancing quality system processes. These corrective actions were thoroughly reviewed during the current inspection and deemed satisfactory. An ongoing internal investigation regarding stability issues for Azelastine HCl Ophthalmic Solution 0.05% was noted, with the firm committed to notifying the District Office of findings.

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## Related Officers

- [company_representative](https://www.keypedia.com/people/sharon-weitz/3d1133f6-a13d-43f9-ba4a-c6a139a7f0fc)
- [company_representative](https://www.keypedia.com/people/misbah-sherwani/b3f2be93-5166-4a7a-b156-6c3596614d95)
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- [company_representative](https://www.keypedia.com/people/bruce-kutinsky/dd51023d-565e-4bf2-891b-68143d4260d3)

Company: https://www.keypedia.com/companies/akorn-operating-company-llc/347ed7e7-51c4-481b-b84c-3055f99d6288

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