# FDA 483 - Apocus Inc - August 23, 2018

Source: https://www.keypedia.com/records/483/apocus-inc/0d3277a5-14d6-4425-915a-ce3a0c0c0271

> FDA 483 for Apocus Inc on August 23, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apocus Inc
- Inspection Date: 2018-08-23
- Office Name: Dallas District Office
- Summary: The FDA Form 483 details numerous deficiencies in the manufacturing and quality control of sterile drug products. Procedures for preventing microbiological contamination lacked adequate validation of aseptic and sterilization processes. Specifically, the firm did not validate the usage of (b) (4) (b) (4) which are less stringent than manufacturer recommendations, and batch records lacked specifications for the (b) (4) test. Media fills were not conducted under challenging conditions, failing to simulate largest batch sizes or most difficult processing methods, and aseptic operators were not qualified on all media fills. Smoke studies did not adequately mimic critical steps or show proper airflow.

Validation was not conducted for (b) (4) used to sterilize equipment (goggles, air sampling equipment) or for (b) (4) used to depyrogenate glassware. Investigations into unexplained discrepancies or out-of-specification results were not always recorded. An unrepairable HEPA filter leak discovered in November 2017 was not investigated for its impact on previously released sterile products. Actionable microbiological contamination on technician hands in the ISO 5 area during aseptic production was not adequately evaluated, and the affected batch was released. Fibers found in Taurine Injection (Lot08022018@1) were not investigated, and the lot was released.

Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals. Sterility hold time studies were not conducted for in-house sterilized goggles, air

## Related Documents

- [483 - 2015-07-23](https://www.keypedia.com/records/483/apocus-inc/01010a2f-f331-4241-9cd1-d6f8bb83f058)
- [483 - 2017-03-02](https://www.keypedia.com/records/483/apocus-inc/e002fb75-4c9d-4d1f-a512-da4535988a72)
- [483 - 2018-08-23](https://www.keypedia.com/records/483/apocus-inc/125310f3-c546-4acd-9759-937b75c2db11)
- [483 - 2018-08-23](https://www.keypedia.com/records/483/apocus-inc/f1d73870-2b2b-493e-998b-353669369e7b)

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/apocus-inc/acedd89d-9e24-462f-bb59-0664af0b5c4b

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9