# FDA 483 - Apocus Inc - August 23, 2018

Source: https://www.keypedia.com/records/483/apocus-inc/f1d73870-2b2b-493e-998b-353669369e7b

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

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## Details

- Record Type: 483
- Company Name: Apocus Inc
- Inspection Date: 2018-08-23
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: This FDA Form 483 document outlines significant deficiencies in the manufacturing and quality control processes for sterile drug products. The facility's procedures for preventing microbiological contamination are inadequate, lacking proper validation of aseptic and sterilization processes. Specifically, the firm has not validated the use of (b)(4) (b)(4) which are less stringent than manufacturer recommendations, and batch records do not include specifications for the (b)(4) test in sterile drug production, with multiple examples cited.

Media fills are insufficient, failing to simulate largest batch sizes and most difficult sterile processing methods, and aseptic operators are not qualified on all media fills. Smoke studies are also inadequate, not mimicking critical steps or demonstrating proper airflow. Validation is missing for (b)(4) used to sterilize equipment (goggles, air sampling equipment) and for (b)(4) used to depyrogenate glassware.

The firm fails to consistently investigate unexplained discrepancies and batch failures. An unrepairable HEPA filter leak in November 2017 was not investigated for its impact on sterile production since May 2017, nor were smoke studies conducted to verify the repaired filter's integrity. Actionable microbiological contamination on technician hands in the ISO 5 area during aseptic production was not adequately evaluated or remediated. A released batch of Taurine Injection was found to contain fibers, but no investigation was conducted.

Equipment cleaning and maintenance intervals are insufficient. Sterility hold time studies are lacking for in-

## 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/0d3277a5-14d6-4425-915a-ce3a0c0c0271)

## 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