# Aspen SA Sterile Operations (Pty) Ltd. - Inspection Records

Source: https://www.keypedia.com/companies/aspen-sa-sterile-operations-pty-ltd/b4918ce4-3b81-4fb7-bd04-2e1110728456

> Inspection records and compliance data for Aspen SA Sterile Operations (Pty) Ltd. in Port Elizabeth, None. Access full analysis and detailed observations.

---

## Details

- Name: Aspen SA Sterile Operations (Pty) Ltd.
- FEI Number: 3007490529
- City: Port Elizabeth
- State: None
- Country Name: South Africa
- Address Line 1: 8b Gibaud Road
- Zip Code: None
- Business Operations: API/FDF ANALYTICAL TESTING, FDF MANUFACTURE, PACK

## Related Documents

- [FDA Inspection 1326320 - Aspen SA Sterile Operations (Pty) Ltd. - 2026-07-14](https://www.keypedia.com/records/fda_inspections/aspen-sa-sterile-operations-pty-ltd/795f2b24-bd8e-41f5-aff7-ba5a198d204d) — source: FDA, date: July 14, 2026
- [483 - Aspen SA Sterile Operations (Pty) Ltd. - 2024-09-17](https://www.keypedia.com/records/483/aspen-sa-sterile-operations-pty-ltd/c8dfe452-b5b0-48f2-ac5d-06e3ca4b72d2) — source: FDA, date: September 17, 2024
- [483 - Aspen SA Sterile Operations (Pty) Ltd. - 2024-09-17](https://www.keypedia.com/records/483/aspen-sa-sterile-operations-pty-ltd/46e4cb00-f31a-4922-bbf7-1d4c606720d4) — source: FDA, date: September 17, 2024
- [FDA Inspection 1249416 - Aspen SA Sterile Operations (Pty) Ltd. - 2024-09-17](https://www.keypedia.com/records/fda_inspections/aspen-sa-sterile-operations-pty-ltd/497b70c2-980b-462d-8d38-87f99e4c6003) — classification: Official Action Indicated (OAI), source: FDA, date: September 17, 2024
- [483 - Aspen SA Sterile Operations (Pty) Ltd. - 2018-12-04](https://www.keypedia.com/records/483/aspen-sa-sterile-operations-pty-ltd/e74bd9a0-bd9d-4483-bb71-66c2f704eee3) — source: FDA, date: December 4, 2018
- [FDA Inspection 1074310 - Aspen SA Sterile Operations (Pty) Ltd. - 2018-12-04](https://www.keypedia.com/records/fda_inspections/aspen-sa-sterile-operations-pty-ltd/b89dae81-0732-4834-8948-34e3d2b21762) — classification: Voluntary Action Indicated (VAI), source: FDA, date: December 4, 2018
- [FDA Inspection 969055 - Aspen SA Sterile Operations (Pty) Ltd. - 2016-04-19](https://www.keypedia.com/records/fda_inspections/aspen-sa-sterile-operations-pty-ltd/f4fcfa59-634f-4921-95c3-976c1330abfc) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 19, 2016
- [FDA Inspection 882533 - Aspen SA Sterile Operations (Pty) Ltd. - 2014-05-23](https://www.keypedia.com/records/fda_inspections/aspen-sa-sterile-operations-pty-ltd/502c9ddc-131d-4908-a57f-ec687c92a348) — classification: No Action Indicated (NAI), source: FDA, date: May 23, 2014
- [FDA Inspection 786162 - Aspen SA Sterile Operations (Pty) Ltd. - 2012-05-17](https://www.keypedia.com/records/fda_inspections/aspen-sa-sterile-operations-pty-ltd/03a66290-c073-4757-a6eb-f3de4a11067d) — classification: No Action Indicated (NAI), source: FDA, date: May 17, 2012

## Related Companies

- [Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)](https://www.keypedia.com/companies/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/02eeb237-fdd8-40a0-b45c-d4d88f49eb6c)
- [GlaxoSmithKline Biologicals SA](https://www.keypedia.com/companies/glaxosmithkline-biologicals-sa/9a234513-4162-49b8-b149-5c1be5aa9090)
- [Ningbo Shuangcheng Pharmaceutical Co., Ltd](https://www.keypedia.com/companies/ningbo-shuangcheng-pharmaceutical-co-ltd/942c1651-ee36-4163-9687-ca694ddc24d2)
- [Terumo BCT Vietnam Co. Ltd.](https://www.keypedia.com/companies/terumo-bct-vietnam-co-ltd/525a9500-4e19-460d-a654-9385db8249fd)
- [Gland Chemical Private Limited](https://www.keypedia.com/companies/gland-chemical-private-limited/a9851b78-88de-4303-8a8b-7793507fdbde)
- [ENDO USA, Inc.](https://www.keypedia.com/companies/endo-usa-inc/f2df2e47-8303-4a2c-9881-5e2ecef64f22)
- [CareFusion 213, LLC](https://www.keypedia.com/companies/carefusion-213-llc/a1fedbce-120c-4b06-8def-c5a653db579a)
- [Kaysersberg Pharmaceuticals SAS](https://www.keypedia.com/companies/kaysersberg-pharmaceuticals-sas/4f0bba88-dadd-49db-8e17-08165e705377)
- [ENDO Pharmaceuticals Solutions, Inc.](https://www.keypedia.com/companies/endo-pharmaceuticals-solutions-inc/73c5da1a-04ad-4b56-9fae-f0a1371df51f)
- [Baxter Healthcare Corporation](https://www.keypedia.com/companies/baxter-healthcare-corporation/738590ab-c241-4de1-aaec-722e154bfc45)

## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [President at Genpact](https://www.keypedia.com/people/damon-a-growl/b2827f8c-e454-4db3-9285-07d11b964d5a)
- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)