# FDA EIR - Teva Parenteral Medicines, Inc. - April 24, 2012

Source: https://www.keypedia.com/records/eir/teva-parenteral-medicines-inc/b299d610-ae8c-472a-874f-b86459f675d6

> FDA EIR for Teva Parenteral Medicines, Inc. on April 24, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Teva Parenteral Medicines, Inc.
- Inspection Date: 2012-04-24
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection was conducted at Teva Parenteral Medicines Inc. in Irvine, CA, from April 3 to April 24, 2012. This comprehensive Good Manufacturing Practice (GMP) and compliance follow-up inspection, under Compliance Program 7356.002, focused on their parenteral drug manufacturing operations. The inspection identified significant issues, leading to the issuance of a 2-item FDA-483 (Inspectional Observations).

A primary concern was product quality and control, evidenced by multiple Class II and III recalls of sterile injectable products. These recalls involved various products, including Bumetanide Injection, Tobramycin Sulfate Injection, Oxytocin Injection, Medroxyprogesterone Acetate Injectable Suspension, Ifosfamide Injection, and Pancuronium Bromide Injection. The reasons for recall included particulate matter, lack of sterility assurance, impurities, degradation products, and out-of-specification pH.

A critical violation involved the manufacture of Daunorubicin HCl Injection without a fully validated testing method, despite being a drug shortage item. Additionally, previous inspections revealed inadequate stability-indicating methods for other products, contributing to subsequent recalls. The firm's process for Field Alert Reports (FARs) was also reviewed, noting potential issues with reporting timeframes.

Teva Parenteral Medicines Inc. was required to address these deficiencies, demonstrating effective remediation and robust quality systems to ensure the safety, identity, strength, quality, and purity of its drug products.

## Related Documents

- [483 - 2009-07-24](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/823311f0-8e08-4dd3-afe8-5e78fdadf779)
- [483 - 2021-08-20](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/b639b463-9013-4135-a37d-81c31801d356)
- [EIR - 2010-05-14](https://www.keypedia.com/records/eir/teva-parenteral-medicines-inc/6a358c56-b202-4ff2-beac-e0b9413decf7)
- [483 - 2013-06-04](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/a341f217-c45e-4025-8a02-d53234f20847)
- [483 - 2012-04-24](https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/f7a6bed1-b9b0-4d1c-9a00-118a6663a935)

## Related Officers

- [Caryn Mcnab](https://www.keypedia.com/people/caryn-mcnab/05d5f65d-5ab2-4798-a3a2-2798a82237e1)
- [Laboratory Director](https://www.keypedia.com/people/jennifer-m-gogley/2025f306-80a6-4222-89ac-e4138028292a)
- [company_representative](https://www.keypedia.com/people/manjula-ghosh/26b4f832-70fe-4394-96f9-40be06f334c4)
- [investigator](https://www.keypedia.com/people/bichsa-tran/6d902c39-50d1-4ee5-84db-2050933cf17b)
- [company_representative](https://www.keypedia.com/people/adam-fox/73741c7d-64d6-4630-a0cc-c33a114cab81)

Company: https://www.keypedia.com/companies/teva-parenteral-medicines-inc/0fca6486-3040-4806-b72d-ff1c31d675c1

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b