# FDA 483 - Teva Parenteral Medicines, Inc. - July 24, 2009

Source: https://www.keypedia.com/records/483/teva-parenteral-medicines-inc/823311f0-8e08-4dd3-afe8-5e78fdadf779

> FDA 483 for Teva Parenteral Medicines, Inc. on July 24, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Teva Parenteral Medicines, Inc.
- Inspection Date: 2009-07-24
- Product Type: Drugs
- Office Name: Los Angeles District Office
- Summary: The FDA Form 483 details numerous deficiencies at a drug manufacturing facility. The quality control unit lacks responsibility for approving/rejecting procedures impacting drug product identity, strength, quality, and purity. The company failed to submit post-approval or change-being-effected changes for a BI challenge in steam sterilization.

Several issues relate to product testing and release:
- Out-of-trend bacterial endotoxin results were observed in finished product lots (e.g., MIR 09-003, MIR 09-015).
- Drug product release does not include appropriate laboratory determination of conformance to final specifications.
- There is no assurance that Propofol Injectable Emulsion 1% is free of bacterial endotoxin.
- In-process materials are not tested for quality/purity or approved/rejected by QC.
- Bioburden levels are sampled from non-sterile bulk solution and end-of-run samples (aseptically filled vials prior to sterilization).
- Acceptance criteria for QC sampling/testing are inadequate to assure batches meet statistical quality control criteria.

Investigation failures include:
- Unexplained discrepancies are not thoroughly reviewed, even for distributed batches.
- Investigations do not extend to other batches or drug products potentially affected.
- No consideration was given to other Propofol products manufactured on the same filling line.

Quality system and documentation issues:
- QC unit responsibilities and procedures are not in writing.

## Related Documents

- [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)
- [EIR - 2012-04-24](https://www.keypedia.com/records/eir/teva-parenteral-medicines-inc/b299d610-ae8c-472a-874f-b86459f675d6)
- [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)

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

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