# FDA 483 - AstraZeneca Pharmaceuticals LP - June 07, 2024

Source: https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/6809d725-a3ed-4b2b-b0a2-b81cc7e01672

> FDA 483 for AstraZeneca Pharmaceuticals LP on June 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AstraZeneca Pharmaceuticals LP
- Inspection Date: 2024-06-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center received a Form 483 citing four observations related to significant manufacturing and quality control deficiencies. Issues include unmitigated contamination risks in drug substance upstream manufacturing, deficient procedures for cleaning and facility maintenance, inadequate documentation of product quality impact from quality events, and a lack of audit trail review for analytical instruments. This inspection highlights repeat observations regarding system deficiencies.

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- [WARNING_LETTER - 2023-08-15](https://www.keypedia.com/records/warning_letter/astrazeneca-pharmaceuticals-lp/ffb41aa4-e9b4-4e4e-b72f-9cf78acb857c)
- [483 - 2024-06-07](https://www.keypedia.com/records/483/astrazeneca-pharmaceuticals-lp/f295582f-0d0d-456b-8a87-9c3c9acec931)

## Related Officers

- [Liqun Zhao](https://www.keypedia.com/people/liqun-zhao/6fdfb753-7788-4351-9b0b-65e06c201bc5)
- [Vidya B. Pai](https://www.keypedia.com/people/vidya-b-pai/bbe3989c-b7b0-40a0-ae0b-a35c81cdd179)
- [Christina Farris](https://www.keypedia.com/people/christina-farris/cf4c3a4d-bf6e-424a-9e7d-f5dd32e41769)
- [Kristen Nickens](https://www.keypedia.com/people/kristen-nickens/d68c87e1-e14c-48f7-86e9-686a3870c777)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/astrazeneca-pharmaceuticals-lp/6f9abb75-9352-43df-b761-026089396fa3

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd