# FDA 483 - Surgery Pharmacy Services Inc - July 07, 2023

Source: https://www.keypedia.com/records/483/surgery-pharmacy-services-inc/ce0ecfc3-696e-459b-9d88-ec6734b3ec22

> FDA 483 for Surgery Pharmacy Services Inc on July 07, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgery Pharmacy Services Inc
- Inspection Date: 2023-07-07
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: This FDA Form 483 was issued to Surgery Pharmacy Services Inc, a producer of sterile drug products located at 3908 Tennessee Ave Ste F, Chattanooga, TN. The inspection, conducted from June 20 to July 7, 2023, by Investigator Jared P Stevens, identified three observations.

Observation 1 noted inadequate smoke studies under dynamic conditions. Videos from April 13, 2023, failed to show manipulations representative of actual compounding processes using the [(b)(4)], such as additions of small volumes, TPN bag connections, powered-on equipment, and connections to all component stations.

Observation 2 cited the failure to conduct media fills that closely simulate aseptic production operations under worst-case, most-challenging, and stressful conditions. Specifically, media fills did not reproduce manipulations made during production, such as the addition of small volumes via the [(b)(4)] machine.

Observation 3 indicated that the facility's design and operation might permit the influx of lesser quality air into a higher quality air area. Material flow directly from an unclassified area into an ISO 7 classified sterile production room occurred via an unfiltered [(b)(4)]. On June 21, 2023, materials (calibration kit, tubing, bags) entered the ISO 7 area, and finished TPN products exited, through this unfiltered [(b)(4)], which was approximately three feet from an ISO 5 hood used

## Related Documents

- [483 - 2019-12-06](https://www.keypedia.com/records/483/surgery-pharmacy-services-inc/454c4048-aaeb-492e-821a-b59c2ce534fc)
- [WARNING_LETTER - 2019-12-06](https://www.keypedia.com/records/warning_letter/surgery-pharmacy-services-inc/752522d8-f6d1-4271-8227-362fb4a1eef3)
- [483 - 2023-07-07](https://www.keypedia.com/records/483/surgery-pharmacy-services-inc/24e7982b-d6aa-4662-af17-92e944882b33)
- [483_RESPONSE - 2023-07-14](https://www.keypedia.com/records/483_response/surgery-pharmacy-services-inc/72191525-9b0a-4886-a6cb-bfd43248b313)

## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)

Company: https://www.keypedia.com/companies/surgery-pharmacy-services-inc/bdd9654b-5696-45c0-a8ca-9a3346ced436

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7